Senior Quality Lead – GMP Compliance & Batch Release

Aquestive-Therapeutics-Inc; Portage (IN); On-site; USD 85,000 - 125,000; Full time

Job summary

Aquestive Therapeutics, Inc. in Portage, IN is seeking a Quality Assurance professional to ensure compliance with pharmaceutical GMPs and company policies.

The role includes reviewing quality documentation, releasing batches for market, and coordinating with QC, Manufacturing and Supply Chain to ensure timely product release. The candidate should have a BS in a science field and 5+ years of pharma/biotech experience, with knowledge of CFR 210/211 and a track record in batch release and QA

Qualifications

• BS degree preferred in chemistry, biochemistry, pharmacy or related science field (as listed).
• Minimum 5+ years in pharmaceutical/biotech industry preferred.
• Experience with Drug Product review and release.
• Knowledge of CFR 210, 211 regulations and GMPs.

Responsibilities

• Verify batches comply with GMP 21 CFR 210/211 and other regulatory requirements by reviewing manufacturing records and testing data.
• Provide batch disposition and release to market and issue COA/Conformance per country requirements.
• Manage internal batch release process with Quality Control, Manufacturing and Supply Chain.
• Communicate batch release status to partners and respond to questions promptly.
• Coordinate batch release activities and close out investigations and related documentation.

Skills

Quality Assurance

GMP Knowledge

Documentation Review

Batch Release Coordination

Regulatory Compliance

Education

BS in Chemistry/Biochemistry/Pharmacy

Tools

QMS Software

Job description

Aquestive Therapeutics, Inc. in Portage, IN is seeking a Quality Assurance professional to ensure compliance with pharmaceutical GMPs and company policies.

The role includes reviewing quality documentation, releasing batches for market, and coordinating with QC, Manufacturing and Supply Chain to ensure timely product release. The candidate should have a BS in a science field and 5+ years of pharma/biotech experience, with knowledge of CFR 210/211 and a track record in batch release and QA