What are the responsibilities and job description for the QA Specialist – Quality Systems & Operations (3-Month Contract) position at AL Solutions?
QA Specialist – Quality Systems & Operations (3-Month Contract) | GMP | Onsite
I’m currently partnered with a biologics-focused CDMO who are continuing to scale their GMP manufacturing operations as they move towards commercial readiness in the US. As part of this expansion, they are looking to bring on an experienced QA Specialist (Quality Systems & Operations) on an initial 3-month contract, with strong likelihood of extension.
The Role
This is a hands-on QA position supporting both Quality Systems and GMP Operations, playing a key role in ensuring compliance across manufacturing, QC, and quality processes. You will be embedded within the QA team, supporting real-time operations while also contributing to core quality systems and investigations.
Key responsibilities include:
- QA review and approval of analytical methods, validation, and QC documentation
- Review of equipment qualification records (URS, IQ, OQ, PQ)
- Supporting deviations, CAPAs, OOS/OOT investigations, and root cause analysis
- QA oversight of GMP manufacturing activities and on-the-floor support
- Review and approval of batch records, SOPs, and GMP documentation
- Contributing to Quality Systems (Deviations, Change Controls, Investigations)
- Cross-functional collaboration with Manufacturing, QC, Analytical Development, and Engineering
What They’re Looking For
- 5-8 years of experience within GMP-regulated environments (pharma, biotech, CDMO)
- Strong background in QA Operations and/or Quality Systems
- Experience supporting deviations, investigations, and CAPAs
- Prior exposure to GMP manufacturing environments (highly preferred)
- Solid understanding of GMP regulations (FDA, EU, 21 CFR Part 210/211)
- Ability to operate in a fast-paced, cross-functional environment
Why This Role?
- Join a company undergoing significant GMP expansion and commercial growth
- High-impact role supporting manufacturing and quality operations in real time
- Exposure across both Quality Systems and QA Operations
- Fast-moving process with immediate start available
- Strong potential for extension beyond the initial 3-month contract
If this sounds interesting, feel free to apply or message George Higginson directly for a confidential discussion.