QA Specialist IV (Houston, TX)Apply Now
Location: Houston, Texas 77047
Employment Type: Contract
Contract Length: 12+ months
- Verification of the company’s compliance with ISO/cGMP quality system requirements as well as knowledge of PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex
- Provide immediate support to operations and quality control staff to address compliance related concerns (QA on-the-floor support).
- Make independent quality-related decisions based on regulatory and compliance knowledge and provide independent quality support to project teams.
- Audit internal quality system elements in manufacturing and operational support areas.
- Direct QA commercial drug substance/drug product experience required or an equivalent amount of aseptic processing and cell therapy manufacturing experience. GMP compliance and Part 11 compliance knowledge preferred.
- Experience with oversight of aseptic processing and the associated international aseptic processing regulations.
- Excellent written and oral communication to include accurate and legible documentation skills; ability to work in a fast-paced environment; team oriented; independent work skills and a strong work ethic.
- The ability to interface and communicate directly with clients is required.
- Microsoft Office and database management skills, organization skills, record keeping skills and ability to handle multiple projects.
- 10+ Years Experience
Trevor HoffmanPrincipal Recruiter
Trevor recruits for JVT's Life Sciences and Technology Practices where he specializes in finding, screening, and placing top-tier industry innovators at companies across multiple markets and verticals.
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