Quality Assurance Manager – Materials Release at Zoetis

Lincoln, Nebraska, United States

Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Animal Health, Pharmaceuticals, ManufacturingIndustries

B.A. or B.S. in Sciences or related field and at least 10 years of relevant experience
Experience with label printing and/or plastic molding (preferred)
Leadership and/or supervisory experience (preferred)
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
Ability to sit, stand and walk
Some travel may be required
Occasional overtime/weekend work

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