Quality Assurance Manager/Team Leader
| Company | Zoetis |
|---|---|
| Location | Atlanta, GA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior, Expert or higher |
Requirements
- B.A. or B.S. in Sciences or related field and at least 10 years of relevant experience.
- 3+ years of supervisory experience preferred.
- Risk Management
- Investigation and Problem Solving
- Demonstrated technical capabilities.
- Ability to establish appropriate timelines to meet key milestones under minimal supervision.
- Deep 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.
- 6-sigma, lean or statistical skills.
Responsibilities
- Provide QA leadership and support for product process validation activities for mAbs/ABI/BPM/Pharmaceutical and Bio-packaging Operations.
- Ensure cGMP compliance within the Biological and Pharmaceutical Operations systems.
- Interpret and enforce FDA, USDA, EMA, and other regulatory guidelines.
- Provides guidance and support within cGMP systems for site colleagues.
- Support regulatory agency, customer, and internal audits.
- Review and approval of action items / commitment tracking items.
- Review and approval of investigation and interim reports.
- Support market action activities.
- Oversee internal audits.
- Participate in change management activities.
- Assist in the review and assessment of Zoetis Quality Standards (ZQS).
- Collect and communication of site and department metrics.
- Maintain department Standard Operating Procedures (SOPs).
- Other responsibilities as assigned.
Preferred Qualifications
- Previous experience with methods in biologicals and/or pharmaceutical manufacturing and packaging.
- Demonstrated knowledge of the Deviation (Trackwise), Change Control (Trackwise), ValGenesis, 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.