This Jobot Job is hosted by: Maria Reyes Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $115,000 - $130,000 per year A bit about us: We are a leading cooperative owned by family farmers across the United States. Committed to delivering wholesome dairy products to consumers globally, our company plays a vital role in supporting sustainable farming practices, innovation, and the dairy industry's growth. As we continue to lead in the production and distribution of high-quality dairy products, we are looking for individuals who share our passion for agriculture, sustainability, and making a positive impact on the world. Why join us? We offer Competitive salaries and benefits! Great PTO Annual bonus & relocation assistance! Job Details Ensure adherence to regulatory requirements and internal FSQ programs/standards. Oversee daily plant Quality and Food Safety operations in alignment with our policies, procedures, customer requirements, and applicable regulations. Take responsibility for the Food Safety and Quality Plans, including supporting prerequisite programs. Enhance and maintain plant policies, procedures, and practices to uphold a cGMP environment. Collaborate cross-functionally to assess and maintain an effective plant hygiene plan. Manage the PEM Program to ensure holistic management of food safety issues and implement effective corrective actions. Supervise plant sanitation to support a robust sanitation program within a cGMP environment. Ensure the effectiveness of plant pest control programs through current, followed, and proactive maintenance. Manage the facility's change control program to enable robust risk assessment and decisions. Lead investigations related to non-conforming events, identifying root causes and implementing effective resolutions. Maintain the CAPA program. Collaborate with R&D during new/reformulated product introductions to ensure compliance with established specifications and regulatory requirements. Act as the point of contact for customer-related issues, complaints, or inquiries. Lead plant complaint investigations, ensuring thorough, effective, timely, and customer-facing responses. Monitor compliance with customer expectations and specifications, communicating any issues or concerns. Maintain plant preparedness for customer and regulatory audits/visits. Provide Leadership: Serve as a key member of the plant leadership team. Collaborate with Operations to foster a world-class food safety and quality culture. Cultivate a positive and effective work culture with direct reports. Identify and retain highly effective personnel through proper selection, training/development, and setting expectations for performance. Track and report on plant quality Key Performance Indicators (KPIs). Participate in the annual plant budgeting process. Collaborate with the plant manager to identify key capital projects supporting food safety and quality initiatives. Provide training to plant personnel concerning food safety, FSMA, and regulatory compliance. Offer quality leadership during unplanned events or emergencies. Provide visible leadership by participating in Gemba walks and internal audits. Engage and interact with all personnel regularly, assisting them with challenges and questions concerning food safety. Bachelor's degree required in Food Science, Biological Sciences or related field 5+ years of experience in food processing environment 3+ years of experience managing teams Prefer experience in dairy manufacturing Certification and/or Licenses HACCP certification SQF Practitioner certified or obtain within first 90 days. PQCI certification Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.
May 05, 2024
Full time
This Jobot Job is hosted by: Maria Reyes Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $115,000 - $130,000 per year A bit about us: We are a leading cooperative owned by family farmers across the United States. Committed to delivering wholesome dairy products to consumers globally, our company plays a vital role in supporting sustainable farming practices, innovation, and the dairy industry's growth. As we continue to lead in the production and distribution of high-quality dairy products, we are looking for individuals who share our passion for agriculture, sustainability, and making a positive impact on the world. Why join us? We offer Competitive salaries and benefits! Great PTO Annual bonus & relocation assistance! Job Details Ensure adherence to regulatory requirements and internal FSQ programs/standards. Oversee daily plant Quality and Food Safety operations in alignment with our policies, procedures, customer requirements, and applicable regulations. Take responsibility for the Food Safety and Quality Plans, including supporting prerequisite programs. Enhance and maintain plant policies, procedures, and practices to uphold a cGMP environment. Collaborate cross-functionally to assess and maintain an effective plant hygiene plan. Manage the PEM Program to ensure holistic management of food safety issues and implement effective corrective actions. Supervise plant sanitation to support a robust sanitation program within a cGMP environment. Ensure the effectiveness of plant pest control programs through current, followed, and proactive maintenance. Manage the facility's change control program to enable robust risk assessment and decisions. Lead investigations related to non-conforming events, identifying root causes and implementing effective resolutions. Maintain the CAPA program. Collaborate with R&D during new/reformulated product introductions to ensure compliance with established specifications and regulatory requirements. Act as the point of contact for customer-related issues, complaints, or inquiries. Lead plant complaint investigations, ensuring thorough, effective, timely, and customer-facing responses. Monitor compliance with customer expectations and specifications, communicating any issues or concerns. Maintain plant preparedness for customer and regulatory audits/visits. Provide Leadership: Serve as a key member of the plant leadership team. Collaborate with Operations to foster a world-class food safety and quality culture. Cultivate a positive and effective work culture with direct reports. Identify and retain highly effective personnel through proper selection, training/development, and setting expectations for performance. Track and report on plant quality Key Performance Indicators (KPIs). Participate in the annual plant budgeting process. Collaborate with the plant manager to identify key capital projects supporting food safety and quality initiatives. Provide training to plant personnel concerning food safety, FSMA, and regulatory compliance. Offer quality leadership during unplanned events or emergencies. Provide visible leadership by participating in Gemba walks and internal audits. Engage and interact with all personnel regularly, assisting them with challenges and questions concerning food safety. Bachelor's degree required in Food Science, Biological Sciences or related field 5+ years of experience in food processing environment 3+ years of experience managing teams Prefer experience in dairy manufacturing Certification and/or Licenses HACCP certification SQF Practitioner certified or obtain within first 90 days. PQCI certification Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.
Unit Description: Sodexo Corporate Services is looking for a Catering Event Manager to join our team at Fannie Mae in Reston VA The Catering Event Manager will work closely with clients and customers to book and coordinate services for meetings and events in the client facility. They will coordinate services from the Conference, Catering, Audiovisual and Facilities departments for the successful execution of daily on-site meetings and events. They will also support Virtual Team Building events and play Host to client groups that play Team Building Games, virtually and on-site or hybrid This individual provides oversight at the direction of management on site to coordinate routine work activities of the Events department. Ideal candidate will have experience working in the above-mentioned departments. Knowledge of catering, room and event management systems, AV and technology required. Experience in large scale, multi-day event production preferred. This position requires a candidate that will constantly strive to foster a culture of hospitality and find new and innovative methods to enhance the client meeting and event experience. Duties can include but not limited to: Plans, organizes, staffs, and directs multiple services which generally include: conference services, conference planning, catering, banquets and basic food and beverage hospitality, front desk, housekeeping audiovisual technology, accounting and finance, human resources, sales and marketing The Catering Event Manager holds a key client-facing role as part of the Events team. This person must exhibit confidence and calm under pressure and must have the natural ability to anticipate client and customer needs. This position offers a traditional Business and Industry, predominantly Monday through Friday, schedule. Accrue 3 weeks of paid vacation per year (first year pro-rated based on date of hire). Medical Benefits beginning date of hire, and 401K with company match eligible. What We Offer: Sodexo offers fair and equitable compensation, partially determined by a candidate's education level or years of relevant experience. While the budgeted range for the position is posted, Sodexo salary offers are based on a candidate's specific criteria, like experience, skills, education and training. Qualifications & Requirements: Basic Education Requirement - High School Diploma or GED Basic Management Experience - 1 year Sodexo is an EEO/AA/Minority/Female/Disability/Veteran employer.
May 04, 2024
Full time
Unit Description: Sodexo Corporate Services is looking for a Catering Event Manager to join our team at Fannie Mae in Reston VA The Catering Event Manager will work closely with clients and customers to book and coordinate services for meetings and events in the client facility. They will coordinate services from the Conference, Catering, Audiovisual and Facilities departments for the successful execution of daily on-site meetings and events. They will also support Virtual Team Building events and play Host to client groups that play Team Building Games, virtually and on-site or hybrid This individual provides oversight at the direction of management on site to coordinate routine work activities of the Events department. Ideal candidate will have experience working in the above-mentioned departments. Knowledge of catering, room and event management systems, AV and technology required. Experience in large scale, multi-day event production preferred. This position requires a candidate that will constantly strive to foster a culture of hospitality and find new and innovative methods to enhance the client meeting and event experience. Duties can include but not limited to: Plans, organizes, staffs, and directs multiple services which generally include: conference services, conference planning, catering, banquets and basic food and beverage hospitality, front desk, housekeeping audiovisual technology, accounting and finance, human resources, sales and marketing The Catering Event Manager holds a key client-facing role as part of the Events team. This person must exhibit confidence and calm under pressure and must have the natural ability to anticipate client and customer needs. This position offers a traditional Business and Industry, predominantly Monday through Friday, schedule. Accrue 3 weeks of paid vacation per year (first year pro-rated based on date of hire). Medical Benefits beginning date of hire, and 401K with company match eligible. What We Offer: Sodexo offers fair and equitable compensation, partially determined by a candidate's education level or years of relevant experience. While the budgeted range for the position is posted, Sodexo salary offers are based on a candidate's specific criteria, like experience, skills, education and training. Qualifications & Requirements: Basic Education Requirement - High School Diploma or GED Basic Management Experience - 1 year Sodexo is an EEO/AA/Minority/Female/Disability/Veteran employer.
Job Description The Encore Boston Harbor General Manager will manage the daily operations of their designated restaurant. The General Manager is responsible for operating the outlet efficiently within pre-established cost controls; managing, scheduling and training restaurant staff; monitoring staff performance, maintaining the department in accordance with Health Department standards; and ensuring customer satisfaction through application of outlet and Encore service standards. Responsibilities include, but are not limited to: the management of the restaurant strategy and ensuring alignment with overall Encore Boston Harbor strategy; maximizing opportunities for restaurant and company success; maintaining all Encore Standards: and ensuring excellent guest and team member experience. JOB RESPONSIBILITIES: Ensures all Encore Boston Harbor core values and property and restaurant standards are implemented and applied. Manages short-and long-term restaurant goals, objectives, policies, and operating procedures; monitors and evaluates operational effectiveness; effects changes required for improvement. Identifies key drivers of success. Manages the restaurant performance, and the accuracy, confidentiality, and thoroughness of restaurant policies and procedures; records and reports. Manages the performance of team members under his/her area of responsibility. Monitors all activities of the restaurant to ensure that all applicable internal policies, federal and state laws, rules, regulations and controls property wide are enforced. Ensures restaurant delivers and maintains a maximum level of property-wide service and satisfaction. Facilitates communication throughout the property by organizing and presiding over regularly scheduled meetings with team members within the restaurant and with other restaurants as appropriate to ensure property wide communication. Responsible for hiring, performance management, and employee engagement within the restaurant. Provides training opportunities, constructive and positive feedback to team members within area of responsibility. Creates a motivating environment. Keeps informed of all new developments within the restaurant and makes recommendations designed to maximize restaurant and company success. Effectively manages internal and external guest relations, which will require levels of patience, tact and diplomacy. Responsible for addressing guest and team member issues as appropriate. Manages multiple priorities simultaneously and meets deadlines, often in stressful and high-pressure situations. Must have the ability to promote positive, fair, and ethical relations with all team member, with all Encore contractors, and in all interactions within the Host and Surrounding communities as an ambassador of the Encore brand. Operates the restaurant efficiently within pre-established cost controls. Establishes restaurant business plan by surveying restaurant demand; conferring with people in the community; identifying and evaluating competitors; preparing financial, marketing, and sales projections, analyses, and estimates Ensure staff are diligent in their opening and closing procedures and that the facility is always correctly prepared. Check environmental elements including sound, lighting and temperatures are always correctly set. Conduct effective shift briefings ensuring all staff are aware of VIPs, special occasions, daily specials, product features and property-wide events. Encourage and motivate staff to provide optimum service during all shifts. Share recommendations and guest comments to the Director of Restaurants to reflect guest feedback. Resolves guest's complaints and team member difficulties. Controls purchases and inventory by reviewing and evaluating usage reports; analyzing variances; taking corrective actions. Works closely with the Director of Beverage & Cocktails and the Director of Wine to ensure philosophy and execution of these programs is aligned. Works with the Food & Beverage Training Manager to ensure all ongoing Training Certifications are upheld and the restaurant is compliant with all departmental standards. Works with safety as a priority, and follows restaurant and company safety standards. Maintains relevant knowledge of industry through continuing education and training. Performs any other job-related duties as assigned.
May 01, 2024
Full time
Job Description The Encore Boston Harbor General Manager will manage the daily operations of their designated restaurant. The General Manager is responsible for operating the outlet efficiently within pre-established cost controls; managing, scheduling and training restaurant staff; monitoring staff performance, maintaining the department in accordance with Health Department standards; and ensuring customer satisfaction through application of outlet and Encore service standards. Responsibilities include, but are not limited to: the management of the restaurant strategy and ensuring alignment with overall Encore Boston Harbor strategy; maximizing opportunities for restaurant and company success; maintaining all Encore Standards: and ensuring excellent guest and team member experience. JOB RESPONSIBILITIES: Ensures all Encore Boston Harbor core values and property and restaurant standards are implemented and applied. Manages short-and long-term restaurant goals, objectives, policies, and operating procedures; monitors and evaluates operational effectiveness; effects changes required for improvement. Identifies key drivers of success. Manages the restaurant performance, and the accuracy, confidentiality, and thoroughness of restaurant policies and procedures; records and reports. Manages the performance of team members under his/her area of responsibility. Monitors all activities of the restaurant to ensure that all applicable internal policies, federal and state laws, rules, regulations and controls property wide are enforced. Ensures restaurant delivers and maintains a maximum level of property-wide service and satisfaction. Facilitates communication throughout the property by organizing and presiding over regularly scheduled meetings with team members within the restaurant and with other restaurants as appropriate to ensure property wide communication. Responsible for hiring, performance management, and employee engagement within the restaurant. Provides training opportunities, constructive and positive feedback to team members within area of responsibility. Creates a motivating environment. Keeps informed of all new developments within the restaurant and makes recommendations designed to maximize restaurant and company success. Effectively manages internal and external guest relations, which will require levels of patience, tact and diplomacy. Responsible for addressing guest and team member issues as appropriate. Manages multiple priorities simultaneously and meets deadlines, often in stressful and high-pressure situations. Must have the ability to promote positive, fair, and ethical relations with all team member, with all Encore contractors, and in all interactions within the Host and Surrounding communities as an ambassador of the Encore brand. Operates the restaurant efficiently within pre-established cost controls. Establishes restaurant business plan by surveying restaurant demand; conferring with people in the community; identifying and evaluating competitors; preparing financial, marketing, and sales projections, analyses, and estimates Ensure staff are diligent in their opening and closing procedures and that the facility is always correctly prepared. Check environmental elements including sound, lighting and temperatures are always correctly set. Conduct effective shift briefings ensuring all staff are aware of VIPs, special occasions, daily specials, product features and property-wide events. Encourage and motivate staff to provide optimum service during all shifts. Share recommendations and guest comments to the Director of Restaurants to reflect guest feedback. Resolves guest's complaints and team member difficulties. Controls purchases and inventory by reviewing and evaluating usage reports; analyzing variances; taking corrective actions. Works closely with the Director of Beverage & Cocktails and the Director of Wine to ensure philosophy and execution of these programs is aligned. Works with the Food & Beverage Training Manager to ensure all ongoing Training Certifications are upheld and the restaurant is compliant with all departmental standards. Works with safety as a priority, and follows restaurant and company safety standards. Maintains relevant knowledge of industry through continuing education and training. Performs any other job-related duties as assigned.
$500 Sign On Bonus! PURPOSE OF THIS POSITION The primary purpose of your job position is to perform daily housekeeping tasks needed to maintain the facility in a clean, orderly, and attractive condition in accordance with Birchaven Village policy and procedure, Birchaven Village ethical statement and resident rights. JOB DUTIES/RESPONSIBILITIES Duty 1: Follow safety precautions, including the use of personal protective equipment, when performing tasks using equipment and supplies. Duty 2: Keep work areas free of hazardous objects such as protruding mop/broom handles, unnecessary equipment, supplies, etc. Using the wet floor signs when needed. Duty 3: Disinfect assigned areas with special solutions to prevent spread of disease. Duty 4: To assure premises, equipment, and facility are clean, orderly and attractive at all times. Duty 5: To help answer call lights and let appropriate staff members know the resident's needs. Duty 6: Replenish supplies of soap, towels and other dispensable items. At the end of the shift, return unused supplies to the utility room. Clean cart and equipment leave soiled cleaning cloths, and mops in the designated areas. Duty 7: Update water temperature log, communication book, work list, and write maintenance and floor care slips as needed. Duty 8: Check unlocked doors and windows for general security purposes. Duty 9: Displays service excellence and standards of behavior as evidenced by practicing the mission, vision, and values of the organization to promote resident satisfaction. Duty 10: Complies with organizational policies, procedures, and practices to ensure quality job performance and regulatory compliance. Duty 11: Perform all other duties as assigned by supervisor. REQUIRED QUALIFICATIONS Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to print and speak simple sentences. Ability to apply commonsense understanding to carry out detailed but uninvolved written or oral instructions. Ability to deal with problems involving a few concrete variables in standardized situations. Must be able to relate to and work with ill, disabled, elderly, emotionally upset, and at times hostile people within the facility. PHYSICAL DEMANDS This position requires a full range of body motions with intermittent walking, lifting, bending, squatting, kneeling, twisting, and standing. The associate will be required to walk for up to one hour a day, sit for four to six hours a day and stand for one hour a day. The individual must be able to lift twenty to fifty pounds and reach work above the shoulders. The individual must have good eye-hand coordination and fine finger dexterity for simple grasping tasks. The individual must have excellent verbal communication skills to perform daily tasks. The associate must have corrected vision and hearing in the normal range. This position is classified at risk for possible occupational exposure to blood borne pathogens (HBV, HIV etc.)
May 01, 2024
Full time
$500 Sign On Bonus! PURPOSE OF THIS POSITION The primary purpose of your job position is to perform daily housekeeping tasks needed to maintain the facility in a clean, orderly, and attractive condition in accordance with Birchaven Village policy and procedure, Birchaven Village ethical statement and resident rights. JOB DUTIES/RESPONSIBILITIES Duty 1: Follow safety precautions, including the use of personal protective equipment, when performing tasks using equipment and supplies. Duty 2: Keep work areas free of hazardous objects such as protruding mop/broom handles, unnecessary equipment, supplies, etc. Using the wet floor signs when needed. Duty 3: Disinfect assigned areas with special solutions to prevent spread of disease. Duty 4: To assure premises, equipment, and facility are clean, orderly and attractive at all times. Duty 5: To help answer call lights and let appropriate staff members know the resident's needs. Duty 6: Replenish supplies of soap, towels and other dispensable items. At the end of the shift, return unused supplies to the utility room. Clean cart and equipment leave soiled cleaning cloths, and mops in the designated areas. Duty 7: Update water temperature log, communication book, work list, and write maintenance and floor care slips as needed. Duty 8: Check unlocked doors and windows for general security purposes. Duty 9: Displays service excellence and standards of behavior as evidenced by practicing the mission, vision, and values of the organization to promote resident satisfaction. Duty 10: Complies with organizational policies, procedures, and practices to ensure quality job performance and regulatory compliance. Duty 11: Perform all other duties as assigned by supervisor. REQUIRED QUALIFICATIONS Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to print and speak simple sentences. Ability to apply commonsense understanding to carry out detailed but uninvolved written or oral instructions. Ability to deal with problems involving a few concrete variables in standardized situations. Must be able to relate to and work with ill, disabled, elderly, emotionally upset, and at times hostile people within the facility. PHYSICAL DEMANDS This position requires a full range of body motions with intermittent walking, lifting, bending, squatting, kneeling, twisting, and standing. The associate will be required to walk for up to one hour a day, sit for four to six hours a day and stand for one hour a day. The individual must be able to lift twenty to fifty pounds and reach work above the shoulders. The individual must have good eye-hand coordination and fine finger dexterity for simple grasping tasks. The individual must have excellent verbal communication skills to perform daily tasks. The associate must have corrected vision and hearing in the normal range. This position is classified at risk for possible occupational exposure to blood borne pathogens (HBV, HIV etc.)
$500 SIgn On Bonus! PURPOSE OF THIS POSITION The primary purpose of your job position is to provide clean linens and personal clothing as needed for resident care in accordance with Birchaven Retirement Village policy and procedure, Birchaven Retirement Village ethical statement and resident rights, subject to the employee handbook, and as directed by the Housekeeping and Laundry Supervisor. JOB FUNCTIONS Every effort has been made to make this job description as complete as possible. However, it in no way states or implies that these are the only duties you will be required to perform. The omission of specific statements of duties does not exclude them from the position if the work is similar, related or a logical assignment. REQUIRED QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION AND/OR EXPERIENCE: Must possess, as a minimum, a 10 grade education or up to one month related experience or training; or equivalent combination of education and experience. LANGUAGE SKILLS: Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to print and speak simple sentences. REASONING ABILITY: Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions. Ability to deal with problems involving a few concrete variables in standardized situations. OTHER SKILLS AND ABILITIES: Must be able to relate to and work with ill, disabled, elderly, emotionally upset, and at times hostile people within the facility. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to lift, stand and use hands to finger, handle, or feel objects. The employee frequently is required to walk and talk or hear. The employee is occasionally required to reach with hands and arms and stoop, kneel, crouch, or crawl.
May 01, 2024
Full time
$500 SIgn On Bonus! PURPOSE OF THIS POSITION The primary purpose of your job position is to provide clean linens and personal clothing as needed for resident care in accordance with Birchaven Retirement Village policy and procedure, Birchaven Retirement Village ethical statement and resident rights, subject to the employee handbook, and as directed by the Housekeeping and Laundry Supervisor. JOB FUNCTIONS Every effort has been made to make this job description as complete as possible. However, it in no way states or implies that these are the only duties you will be required to perform. The omission of specific statements of duties does not exclude them from the position if the work is similar, related or a logical assignment. REQUIRED QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION AND/OR EXPERIENCE: Must possess, as a minimum, a 10 grade education or up to one month related experience or training; or equivalent combination of education and experience. LANGUAGE SKILLS: Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to print and speak simple sentences. REASONING ABILITY: Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions. Ability to deal with problems involving a few concrete variables in standardized situations. OTHER SKILLS AND ABILITIES: Must be able to relate to and work with ill, disabled, elderly, emotionally upset, and at times hostile people within the facility. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to lift, stand and use hands to finger, handle, or feel objects. The employee frequently is required to walk and talk or hear. The employee is occasionally required to reach with hands and arms and stoop, kneel, crouch, or crawl.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Description: Senior Principal Associate - QA Site Compliance serves as the site inspection readiness steward to lead the inspection readiness program at the RTP site. The inspection readiness steward will have oversight of the inspection readiness program and processes and provide quality auditing expertise in regulation requirements for all aspects of manufacturing conducted at RTP. Key Objectives/Deliverables: Coordinates and manages regulatory inspections including logistics and data system(s). Implement and Lead the site inspection readiness program Implement and Lead the Quality Oversight program Acts as data steward and trainer for site audit data system(s) Leads inspection readiness huddles Monitor and report on the status and effectiveness of the inspection readiness program and needed improvements Perform local site impact assessments in response to Lilly site external inspection findings and external trendings in accordance with Lilly's regulatory change management program. Ensure awareness of applicable regulatory requirements and quality management system requirements throughout the organization Leads site initiatives related to quality and compliance; supports network initiatives related to quality and compliance for local implementation Serve as a quality and technical mentor/coach for interpretation and application of regulatory and global requirements for individual contributors and management at the site Lead and model behaviors foundational to strong quality culture Performs site self-inspections, as necessary Support site safety initiatives. Basic Requirements: BSc or MSc in scientific/technical discipline: chemistry, biology, microbiology, engineering or equivalent scientific/technical degree 10+ years of experience in pharmaceutical and/or medical device industry Preferred attributes but not required: Extensive knowledge of external Regulations and Lilly Quality System requirements Ability to function in a team environment as a leader and as a team member Demonstrated ability to partner/network with other sites Demonstrated participations in inspections and inspection readiness activities including acting as an audit host. Demonstrated ability to manage projects. Proficiency with computer systems. Multi product facility knowledge including parenteral drug product manufacturing, device assembly and packaging activities Good knowledge of cGMPs, ISO and quality management systems with demonstrated technical proficiency Strong communication and interpersonal skills with ability to influence multiple levels of the organization Strong self-management and organizational skills, ability to prioritize, critical decision-making skills, problem solving, mentorship and coaching skills. Self-motivation, lead the way for ensuring a fair and equitable work environment. Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals Additional Information: US/OUS travel may be required Flex hours possible Site operates 24/7 - overtime may be required Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
Apr 09, 2024
Full time
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Description: Senior Principal Associate - QA Site Compliance serves as the site inspection readiness steward to lead the inspection readiness program at the RTP site. The inspection readiness steward will have oversight of the inspection readiness program and processes and provide quality auditing expertise in regulation requirements for all aspects of manufacturing conducted at RTP. Key Objectives/Deliverables: Coordinates and manages regulatory inspections including logistics and data system(s). Implement and Lead the site inspection readiness program Implement and Lead the Quality Oversight program Acts as data steward and trainer for site audit data system(s) Leads inspection readiness huddles Monitor and report on the status and effectiveness of the inspection readiness program and needed improvements Perform local site impact assessments in response to Lilly site external inspection findings and external trendings in accordance with Lilly's regulatory change management program. Ensure awareness of applicable regulatory requirements and quality management system requirements throughout the organization Leads site initiatives related to quality and compliance; supports network initiatives related to quality and compliance for local implementation Serve as a quality and technical mentor/coach for interpretation and application of regulatory and global requirements for individual contributors and management at the site Lead and model behaviors foundational to strong quality culture Performs site self-inspections, as necessary Support site safety initiatives. Basic Requirements: BSc or MSc in scientific/technical discipline: chemistry, biology, microbiology, engineering or equivalent scientific/technical degree 10+ years of experience in pharmaceutical and/or medical device industry Preferred attributes but not required: Extensive knowledge of external Regulations and Lilly Quality System requirements Ability to function in a team environment as a leader and as a team member Demonstrated ability to partner/network with other sites Demonstrated participations in inspections and inspection readiness activities including acting as an audit host. Demonstrated ability to manage projects. Proficiency with computer systems. Multi product facility knowledge including parenteral drug product manufacturing, device assembly and packaging activities Good knowledge of cGMPs, ISO and quality management systems with demonstrated technical proficiency Strong communication and interpersonal skills with ability to influence multiple levels of the organization Strong self-management and organizational skills, ability to prioritize, critical decision-making skills, problem solving, mentorship and coaching skills. Self-motivation, lead the way for ensuring a fair and equitable work environment. Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals Additional Information: US/OUS travel may be required Flex hours possible Site operates 24/7 - overtime may be required Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.