Quality Assurance Manager/Team Leader - mAbs/B2 Operations

About the role

Zoetis is the world's largest Manufacturer and Supplier of Animal Pharmaceuticals. Our plant has been recognized as one of the Nebraska's Safest Companies, with a long-standing presence in Lincoln and we continue to grow.

Responsibilities

• Provide QA support for product process validation activities for MAb manufacturing
• Provide QA support for MAb product registrations and compliance
• Maintain the site's compliance with Zoetis Quality standards
• Review and approve action items / commitment tracking items
• Support regulatory agency, customer, and internal audits
• Review and approve investigation and interim reports
• Support market action activities
• Perform internal audits (external audits as necessary)
• Batch record review, intermediate product release
• Participation in change management activities
• Aid in the review and assessment of Zoetis Quality Standards (ZQS)
• Collection and communication of site and department metrics
• Maintain department Standard Operating Procedures (SOPs)
• Other responsibilities as assigned

Requirements

Minimum Qualifications:

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

Qualifications

Preferred Qualifications:

• Previous experience with methods in protein purification
• Demonstrated knowledge of the Deviation (ETS), Change Control (ETS), Equipment Change Control (CCDB) database, 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, and process deviation investigations

Benefits

• Great Health Benefits from day 1!
• 4 weeks accrued paid vacation and 13 paid holidays
• 401(k) match with company profit sharing
• Tuition reimbursement
• Student Loan Repayment Program

Pay

N/A

Schedule

N/A