Quality Assurance Compliance Specialist – Component Inspection

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

We are seeking a detail-oriented and experienced Compliance Specialist to join our team. The successful candidate will be responsible for developing and implementing inspection specifications for components used in our manufacturing processes. This role ensures that all components meet the required standards and regulatory guidelines, contributing to the production of safe and effective pharmaceutical products. It requires exceptional written communication skills, technical expertise, and the ability to collaborate with cross-functional teams. Proficiency in MS Word is required, and experience with Veeva Vault, SAP QM, and TrackWise is highly desirable.

Hours: 1st shift. Evening and weekend work may be required.

Position Responsibilities

• Develop Inspection Specifications: Create detailed inspection criteria for raw materials, in-process samples, and finished components to ensure compliance with quality standards.
• Implement Inspection Procedures: Establish and maintain standard operating procedures (SOPs) for component inspection, ensuring consistency and accuracy in testing.
• Conduct Testing: Perform routine and non-routine testing of components using various analytical techniques and instrumentation.
• Document Results: Maintain accurate and thorough records of all inspection activities, test results, and any deviations from specifications.
• Ensure Compliance: Adhere to current good manufacturing practices (cGMP) and other regulatory requirements in all inspection activities.
• Collaborate with Teams: Work closely with manufacturing, R&D, and regulatory affairs teams to ensure seamless integration of inspection criteria into the production process.
• Investigate Issues: Identify and report any quality issues or deviations and participate in root cause analysis and corrective action implementation utilizing ETS-Event Tracking System (Trackwise).
• Continuous Improvement: Participate in continuous improvement initiatives to enhance inspection processes and overall product quality.
• Train Staff: Provide training and guidance to junior staff and other team members on inspection procedures, quality standards, and LIMS.

Education and Experience

Bachelor’s degree in a technical discipline (e.g., Chemistry, Biology, Engineering) or related scientific field.

• For GJL 040-1 level
  • 1-2 years’ experience in pharmaceutical/biotechnology manufacturing or quality.
• For GJL 040-2 level
  • 3-5 years’ technical writing experience in pharmaceutical, biotechnology, or life sciences industry.

Technical Skills and Competencies Requirement

• Technical Skills: Proficiency in analytical techniques and instrumentation used in component inspection.
• Regulatory Knowledge: Strong understanding of cGMP and other relevant regulatory guidelines
• Attention to Detail: Exceptional attention to detail and accuracy in testing and documentation.
• Communication Skills: Excellent verbal and written communication skills
• Teamwork: Ability to work effectively in a team-oriented environment
• Problem-Solving: Strong analytical and problem-solving skills
• Adaptability: Ability to adapt to changing priorities and work in a fast-paced environment

Preferred Qualifications:

• Experience: Minimum of 3-5 years of experience in quality control or quality assurance within the pharmaceutical industry
• Proficient: MS Word, MS Excel, Veeva Vault, Trackwise, and SAP

Physical Position Requirements

• This position requires sitting, standing, and walking with occasional overtime/weekend work.
• Lift materials up to 40lbs
• Must wear appropriate PPE (Personal Protective Equipment) when required.

Full time

Regular

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