Quality Assurance Associate Compliance Specialist

- Zoetis India Capability Center; Oklahoma; On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Paid vacation

13 paid holidays

401(k) match

Tuition reimbursement

Health benefits from day 1

Job summary

Zoetis Lincoln facility is seeking a Quality Assurance professional to provide on-the-floor QA support for antigen and monoclonal antibody production, including batch record review and quality assessments.

The role interfaces with regulatory agencies, customers, and internal auditors, reporting to the B2 QA Team Lead. 1st shift availability and cross-functional collaboration required.

Qualifications

• Ability to perform investigation and root-cause analyses.
• Knowledge of local, federal, and international regulations.
• Strong written and verbal communication skills in English.

Responsibilities

• Perform batch record review and product release activities.
• Review and approve deviation investigations and corrective actions.
• Review and approve change controls for manufacturing documents and procedures.
• Provide QA support for product transfers and process improvements.
• Conduct internal audits and support regulatory inspections.

Skills

Problem solving

Regulatory knowledge

Documentation

Communication

Teamwork

Microsoft Office

Education

Associates degree

Bachelor's degree

Job description

Zoetis is the world's largest Manufacturer and Supplier of Animal Pharmaceuticals. At Zoetis in Lincoln, NE, we manufacture high quality medicines for dogs, cats, and livestock. Our plant has been recognized as one of the Nebraska’s Safest Companies, with a long-standing presence in the Lincoln community. We are a clean, modern site that continues to innovate and grow.

Benefits Include

• 4 weeks accrued paid vacation and 13 paid holidays.
• 401(k) match with company profit sharing.
• Tuition reimbursement and Student Loan repayment program.
• Great Health, personal, and family benefits starting day 1.

Position Summary

This position provides Quality Assurance support for Lincoln manufacturing operations, supporting the biological and biopharmaceutical manufacturing process teams. This position is responsible for providing on-the-floor Quality Assurance support functions for antigen and monoclonal antibody production by performing for real-time batch record review, quality assessments, deviation decisions and change control activities. This position will also interface directly with regulatory agency, customers, and internal auditors, and provide support with site and department metrics. This position reports to the B2 Quality Assurance Team Lead, and will work closely with Manufacturing, Materials Management / Production Scheduling, Quality Operations laboratories, Regulatory and Site Leadership.

Hours: 1st Shift.

Position 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.
• Additional responsibilities as assigned.

Education and Experience

Job level based on years of relevant experience:

For the 040-1 grade level

• Associates degree
• Minimum 3-5 years of progressive experience at the OTE Lead level or above, in Manufacturing or Quality Operations

For the 040-2 grade level

• Bachelor's degree
• Greater than 4 years' experience at an Associate Staff level position in Manufacturing or Quality Operations.

Technical Skills and Competencies Required

Minimum Qualifications

• 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

Preferred Qualifications

• 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.

Physical Position Requirements

• Lift materials up to 40lbs
• Ability to sit, stand and walk
• Some travel may be required

Full time

Regular

Colleague

Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.

Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but