Quality Assurance Manager - Materials Release

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

The Materials Release QA Manager is responsible for QA oversight of incoming inspection, warehousing and shipping, sampling and release of raw materials, packaging and labeling components, and contracted intermediates/finished goods. This position is responsible for the direct supervision of the teams performing these functions. As needed, the Materials Release QA Manager will interface directly with customer and internal auditors, regulatory inspectors and provide guidance and support in the interpretation and enforcement of regulatory guidelines.

Hours: 1st shift.

Position Responsibilities

• Oversee and manage the incoming inspection and raw material release teams.
• Ensure the accurate and efficient preparation of all release documents (raw material, certificates/declarations, etc.). Ensure all materials are compliant with the registered specifications and that releases occur in timely manner. Support the quality of materials and products in a GMP environment.
• Create and revise material specifications. Ensure the appropriate specifications are in-place.
• Monitor and identify regulatory/compendial changes affecting raw material requirements.
• Support Periodic Product Reviews (PPRs) for Raw Materials and Packaging Components
• Identify and communicate metrics (e.g., release timelines); track RFT on incoming shipments.
• Identify and escalate areas of risk, particularly those with vendors and materials.
• Identify and drive to resolution areas of risk associated with vendors and materials.
• Support the qualification of new vendors/materials.
• QA oversight of the in-coming materials and outgoing finished goods warehouses.
• Support site project initiatives.
• Lead/participate in investigations and change management activities.
• Support regulatory agency, customer, and internal audits.
• Support market action activities.
• Maintain the department Standard Operating Procedures and compliance with the Zoetis Quality standards.
• Other responsibilities, as assigned.

Education and Experience

B.A. or B.S. in Sciences or related field and at least 10 years of relevant experience.

Technical Skills and Competencies Required

• Experience with label printing and/or plastic molding (preferred).
• Leadership and/or supervisory (preferred) experience.
• Knowledge of USDA, FDA, and EU regulations, with an emphasis on FDA regulations and requirements.
• Experience in change management processes, regulatory compliance, quality operations, manufacturing for vaccines and/or bio/pharmaceutical manufacturing operations.
• Demonstrated investigation, problem solving and risk assessment/management skills.
• Organizational skills, attention to detail.
• Excellent verbal and written communication skills .
• Works effectively in a team-based environment.
• Demonstrated ability to work with internal and external colleagues.
• Demonstrated knowledge of the Deviation (ETS), Change Control (ETS), Veeva Vault, ERP (SAP) and Laboratory Information Management (LIMS) systems.

Physical Position Requirements

• Ability to sit, stand and walk.
• Some travel may be required.
• Occasional overtime/weekend work

Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.

Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.