QA Specialist / Associate Manager
Quality Assurance Specialist / Associate Manager (Sterile Compounding)
Tampa, FL | Onsite
The Opportunity
This is a high-impact QA hire at a sterile compounding pharmaceutical manufacturer supporting the upcoming launch of a flagship product expected to become the company's largest line.
This isn't a maintenance QA role. You'll step in and take ownership of quality systems on-site, working in a fast-paced, build-and-improve environment where your work directly impacts product launch and ongoing operations.
What You'll Be Doing
- Own and maintain site-level Quality Management Systems (QMS)
- Support sterile manufacturing operations and ensure product quality
- Drive cGMP compliance and overall quality system maturity
- Oversee deviations, CAPAs, change controls, and investigations
- Provide regulatory and compliance oversight across operations
- Review and support packaging and labeling processes
- Partner cross-functionally with manufacturing, technical ops, and leadership
- Help prepare the site for increased scale and inspection readiness
What They're Looking For
- 5+ years of Quality Assurance experience in pharmaceutical manufacturing
- Strong background in sterile or aseptic environments
- Experience in 503B outsourcing facilities or sterile compounding required
- Hands-on experience with QMS elements (deviations, CAPA, change control, batch review)
- Familiarity with cGMP regulations and regulatory expectations
- Understanding of multi-state licensing requirements is a plus
- Bachelor's degree in Microbiology, Chemistry, or related scientific discipline
Key Considerations
- Location: Tampa, FL (onsite 5 days/week)
- Level: Senior Specialist / Associate Manager
- Compensation: $120-130K base (total package evolving)
- Structure: Open to contract-to-hire or full-time
- Timing: Urgent hire supporting a near-term product launch
Why This Role
- Ownership of quality systems, not just execution
- Opportunity to step into a critical role during a major product launch
- High visibility with leadership and direct impact on site success
- Environment where you can build, improve, and shape processes vs maintaining legacy systems
FAQs
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