Quality Assurance Compliance Specialist
Zoetis, Inc, Lincoln, NE, United States
Benefits Include:
4 weeks accrued paid vacation and 13 paid holidays.
401(k) match with company profit sharing.
Tuition reimbursement and Student Loan repayment program.
Great Health, personal, and family benefits starting day 1.
Position Summary
This position provides Quality Assurance support for Lincoln manufacturing operations, supporting the biological and biopharmaceutical manufacturing process teams. This position is responsible for providing on-the-floor Quality Assurance support functions for antigen and monoclonal antibody production by performing for real-time batch record review, quality assessments, deviation decisions and change control activities. This position will also interface directly with regulatory agency, customers, and internal auditors, and provide support with site and department metrics. This position reports to the B2 Quality Assurance Team Lead, and will work closely with Manufacturing, Materials Management / Production Scheduling, Quality Operations laboratories, Regulatory and Site Leadership.
Hours: 1st Shift.
Position Responsibilities
Perform routine batch record review and product release functions for assigned support areas within established timelines (e.g. at the end of the shift), ensuring compliance with all applicable regulatory requirements and product registrations.
Support, review and approve deviation investigations, ensuring documentation meets internal and regulatory requirements, is completed within established timelines, and identifies root cause.
Review and approve corrective / preventive actions, ensuring effectiveness of identified actions and completion within identified timelines.
Review and approve change control for manufacturing documents and procedures, ensuring compliance with applicable regulatory standards.
Provide QA support for product transfers and process improvement initiatives.
Review and approve validation protocols and reports.
Perform internal audits of manufacturing operations to ensure compliance with corporate and GMP/ regulatory requirements.
Perform inspection readiness activities and provide QA support during Corporate and Regulatory inspections.
Other responsibilities as assigned.
Education and Experience
Associates degree
Minimum 3-5 years of progressive experience at the OTE Lead level or above, in Manufacturing or Quality Operations
Bachelor's degree
Greater than 4 years' experience at an Associate Staff level position in Manufacturing or Quality Operations.
Technical Skills and Competencies Required
Minimum Qualifications
Investigation and Problem Solving
Demonstrated technical capabilities.
Ability to establish appropriate timelines to meet key milestones under minimal supervision.
Knowledge of local, federal, and international regulations
Knowledge of human error awareness / prevention
Organization skills
Verbal and written communication skills (fluent in English)
Works effectively in a team-based environment
Ability to communicate effectively with Team Members to facilitate completion requests and review from all levels to meet all deadlines.
Proficient in Microsoft Office applications
Attention to detail.
Demonstrated ability to work with internal and external colleagues.
Preferred Qualifications
Previous experience with manufacturing methods for antigen production, media preparation, or monoclonal antibody processes.
Demonstrated knowledge of the Deviation (ETS), Change Control (ETS), ERP (SAP), and Laboratory Information Management (LIMS) systems.
Experience in change management processes, manufacturing operations, quality operations, and/or regulatory affairs.
Previous experience with batch record review, process deviation investigations, and change control.
Physical Position Requirements
Lift materials up to 40lbs
Ability to sit, stand and walk.
Some travel may be required.
Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at zoetiscolleagueservices@zoetis.com to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact.
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4 weeks accrued paid vacation and 13 paid holidays.
401(k) match with company profit sharing.
Tuition reimbursement and Student Loan repayment program.
Great Health, personal, and family benefits starting day 1.
Position Summary
This position provides Quality Assurance support for Lincoln manufacturing operations, supporting the biological and biopharmaceutical manufacturing process teams. This position is responsible for providing on-the-floor Quality Assurance support functions for antigen and monoclonal antibody production by performing for real-time batch record review, quality assessments, deviation decisions and change control activities. This position will also interface directly with regulatory agency, customers, and internal auditors, and provide support with site and department metrics. This position reports to the B2 Quality Assurance Team Lead, and will work closely with Manufacturing, Materials Management / Production Scheduling, Quality Operations laboratories, Regulatory and Site Leadership.
Hours: 1st Shift.
Position Responsibilities
Perform routine batch record review and product release functions for assigned support areas within established timelines (e.g. at the end of the shift), ensuring compliance with all applicable regulatory requirements and product registrations.
Support, review and approve deviation investigations, ensuring documentation meets internal and regulatory requirements, is completed within established timelines, and identifies root cause.
Review and approve corrective / preventive actions, ensuring effectiveness of identified actions and completion within identified timelines.
Review and approve change control for manufacturing documents and procedures, ensuring compliance with applicable regulatory standards.
Provide QA support for product transfers and process improvement initiatives.
Review and approve validation protocols and reports.
Perform internal audits of manufacturing operations to ensure compliance with corporate and GMP/ regulatory requirements.
Perform inspection readiness activities and provide QA support during Corporate and Regulatory inspections.
Other responsibilities as assigned.
Education and Experience
Associates degree
Minimum 3-5 years of progressive experience at the OTE Lead level or above, in Manufacturing or Quality Operations
Bachelor's degree
Greater than 4 years' experience at an Associate Staff level position in Manufacturing or Quality Operations.
Technical Skills and Competencies Required
Minimum Qualifications
Investigation and Problem Solving
Demonstrated technical capabilities.
Ability to establish appropriate timelines to meet key milestones under minimal supervision.
Knowledge of local, federal, and international regulations
Knowledge of human error awareness / prevention
Organization skills
Verbal and written communication skills (fluent in English)
Works effectively in a team-based environment
Ability to communicate effectively with Team Members to facilitate completion requests and review from all levels to meet all deadlines.
Proficient in Microsoft Office applications
Attention to detail.
Demonstrated ability to work with internal and external colleagues.
Preferred Qualifications
Previous experience with manufacturing methods for antigen production, media preparation, or monoclonal antibody processes.
Demonstrated knowledge of the Deviation (ETS), Change Control (ETS), ERP (SAP), and Laboratory Information Management (LIMS) systems.
Experience in change management processes, manufacturing operations, quality operations, and/or regulatory affairs.
Previous experience with batch record review, process deviation investigations, and change control.
Physical Position Requirements
Lift materials up to 40lbs
Ability to sit, stand and walk.
Some travel may be required.
Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at zoetiscolleagueservices@zoetis.com to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact.
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