Quality Assurance Compliance Specialist

Zoetis is the world's largest Manufacturer and Supplier of Animal Pharmaceuticals.

At Zoetis in Lincoln, NE, we manufacture high quality medicines for dogs, cats, and livestock. Our plant has been recognized as one of the Nebraska's Safest Companies, with a long-standing presence in the Lincoln community. We are a clean, modern site that continues to innovate and grow.

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.
  

About Zoetis

At Zoetis, our purpose is to nurture the world and humankind by advancing care for animals. As a Fortune 500 company and the world leader in animal health, we discover, develop, manufacture and commercialize vaccines, medicines, diagnostics and other technologies for companion animals and livestock. We know our people drive our success. Our award-winning culture, built around our Core Beliefs, focuses on our colleagues' careers, connection and support. We offer competitive healthcare and retirement savings benefits, along with an array of benefits, policies and programs to support employee well-being in every sense, from health and financial wellness to family and lifestyle resources.

Notice: Zoetis Recruiters will contact candidates via email from an address ending in @zoetis.com and may also initially connect with candidates through LinkedIn, including LinkedIn InMail. Zoetis does not use Gmail, Outlook, Yahoo, or other web-based/generic email domains to communicate about job opportunities, interviews, or offers of employment. If you receive a recruitment-related email message claiming to be from Zoetis that does not come from @zoetis.com, please treat it as suspicious. For your security, do not reply, click links, open attachments, share personal or financial information, or send money in response to unexpected or questionable recruitment communications.

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