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