QA Compliance Specialist – Biopharma Manufacturing

Zoetis, Inc; Lincoln (NE); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Vacation time & holidays

401(k) match with profit sharing

Tuition reimbursement & student loan

Health & family benefits from day 1

Job summary

Zoetis, Inc. in Lincoln, NE, seeks a Quality Assurance Associate Compliance Specialist to provide on-the-floor QA support for antigen and monoclonal antibody production, including real-time batch record review, deviations, and change control activities.

The role interfaces with regulatory agencies, customers, and internal auditors, supports site metrics, and reports to the B2 QA Team Lead. First shift hours; travel may be required as needed.

Qualifications

• Investigation and problem solving across QA processes.
• Knowledge of local, federal, and international regulations.
• Ability to establish timelines to meet milestones with minimal supervision.
• Verbal and written communication in English; strong documentation.
• Works effectively in a team-based environment.
• Proficient with Microsoft Office applications.
• Ability to coordinate with internal and external colleagues to meet deadlines.

Responsibilities

• Perform routine batch record review and product release functions within established timelines.
• Support, review and approve deviation investigations with root-cause analysis.
• Review and approve corrective/preventive actions and change controls.
• Provide QA support for product transfers and process improvements.
• Review and approve validation protocols and reports.
• Conduct internal audits of manufacturing operations for GMP compliance.
• Support inspections and readiness activities during regulatory audits.
• Tackle additional QA responsibilities as assigned.

Skills

Investigation & problem solving

Regulatory knowledge

Timeline management

English communication

Teamwork

Microsoft Office

Interpersonal collaboration

Cross-functional coordination

Education

Associates degree

Bachelor's degree

Tools

SAP

LIMS

ERP systems

Job description

Zoetis, Inc. in Lincoln, NE, seeks a Quality Assurance Associate Compliance Specialist to provide on-the-floor QA support for antigen and monoclonal antibody production, including real-time batch record review, deviations, and change control activities.

The role interfaces with regulatory agencies, customers, and internal auditors, supports site metrics, and reports to the B2 QA Team Lead. First shift hours; travel may be required as needed.