Quality Assurance Compliance Specialist

Zoetis • Lincoln, NE

1d • Onsite

About The Position

This position provides Quality Assurance support for Lincoln manufacturing operations, supporting the biological and biopharmaceutical manufacturing process teams. This role is responsible for providing on-the-floor Quality Assurance support functions for antigen and monoclonal antibody production by performing real-time batch record review, quality assessments, deviation decisions, and change control activities. The specialist will also interface directly with regulatory agencies, customers, and internal auditors, and provide support with site and department metrics.

Requirements

• 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.
• 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.

Nice To Haves

• 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.

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.

Benefits

• 4 weeks accrued paid vacation
• 13 paid holidays
• 401(k) match with company profit sharing
• Tuition reimbursement
• Student Loan repayment program
• Great Health, personal, and family benefits starting day 1.
• competitive healthcare and retirement savings benefits
• array of benefits, policies and programs to support employee well-being in every sense, from health and financial wellness to family and lifestyle resources.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree
• Number of Employees: 5,001-10,000 employees