
Quality Assurance Pharmaceutical Engineer
1w1 week agoVirbac
Bridgeton, US · Full-time · $95,000 – $130,000
About this role
Virbac Animal Health seeks a Quality Assurance Pharmaceutical Engineer for external functions on the Quality Assurance team. This role assesses Contract Manufacturing Organizations (CMOs) compliance to cGMPs, reviews Batch Records, Change Controls, regulations, and company policies. It provides oversight for material suppliers, service providers, and contract laboratories, with periodic domestic and international travel required.
Conduct supplier qualifications per Virbac policies and regulatory requirements. Assist in developing and maintaining audit schedules. Proactively manage changes in processes following industry practices or regulations to ensure high quality standards.
Review and approve deviations, batch documentation, Out-of-Specification, Out-of-Trend, and change requests from suppliers. Trend performance metrics for suppliers and report regularly to identify potential shifts. A valid passport is required for travel.
Join a company where animal health drives a unique human adventure. Benefit from internal mobility between positions and countries, individual development plans, and a partnership based on trust. Explore new territories while balancing professional and personal lives.
Foster engagement through skill acquisition for tomorrow's challenges and a responsible business approach. Strong preference for candidates in the St. Louis area. Contribute to evolving teams motivated by quality and compliance.
Requirements
- Pharmaceutical Manufacturing and/or Aseptic Manufacturing
- Quality Assurance Auditing and/or Engineering
- Batch Record review for drug and/or sterile products
- Experience with regulatory bodies (FDA, USDA, EMA)
- Knowledge of cGMP compliance and supplier auditing
Responsibilities
- Assess Contract Manufacturing Organizations (CMOs) compliance to cGMPs
- Review Batch Records, Change Controls, applicable regulations and company policies
- Provide Quality Assurance oversight for material suppliers, service providers, and contract laboratories
- Ensure suppliers meet industry and Virbac standards set forth by Regulatory agencies
- Perform supplier qualification per established Virbac policies and regulatory requirements
- Assist in development and maintenance of audit schedules
- Review and approve deviations, batch documentation, Out-of-Specification, Out-of-Trend and change requests from suppliers
- Trend performance metrics for suppliers and report regularly
Benefits
- Competitive Pay and Bonus Opportunity
- 401k Match: 6%
- 13 Company-paid Holidays
- 15 Vacation Days
- 5 Personal Days
- 5 Floating Holidays
- Growth Opportunities
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