Navinta Analytical Assurance Manager

Analytical Assurance Manager - Sterile Pharmaceutical Manufacturing

We're partnering with a growing pharmaceutical manufacturer expanding their sterile manufacturing operations in South Florida. They are looking to bring on an Analytical Assurance Manager to support product quality and analytical oversight within a live GMP environment producing injectable products.

This role sits at the intersection of QA and QC, with strong ownership over investigations, analytical review, and product release support as the site continues to scale.

What you'll be doing:

• Lead and support OOS, OOT, and deviation investigations tied to analytical and manufacturing events
• Review and support raw materials, in-process, and finished product data
• Contribute to batch record review and product release decisions
• Support vendor qualification, material specifications, and SOP development
• Partner closely with QC, Manufacturing, and Quality teams to resolve issues
• Ensure compliance with GMP, data integrity, and regulatory expectations

What we're looking for:

• ~5-8 years of experience in QA, QC, or analytical quality within GMP environments
• Strong experience with investigations (OOS/OOT) and analytical data review
• Background supporting pharmaceutical manufacturing operations
• Familiarity with batch release processes and documentation review
• Strong understanding of GMP and compliance practices

Nice to have:

• Experience in sterile or injectable manufacturing environments
• Exposure to FDA inspections or audit readiness
• Experience working across both QA and QC functions

Additional details:

• Location: Boca Raton, FL
• Schedule: Fully onsite, 5 days per week
• Compensation: Competitive base salary + bonus
• Open to candidates eligible to work in the U.S., including H1B transfers