Senior Quality & Batch Release Specialist

Aquestive Therapeutics, Inc.; Portage, Northern (IN, KY); Hybrid; USD 80,000 - 110,000; Full time

Job summary

Aquestive Therapeutics, Inc. in Portage, IN is seeking a Quality Assurance professional to ensure GMP compliance and regulatory adherence during manufacturing operations.

You will review and release drug product documentation, manage batch disposition, and coordinate with Quality, Manufacturing, and Supply Chain to ensure timely release and accurate investigations. Strong communication and independent decision-making are essential.

Qualifications

• BS degree in chemistry, biochemistry, pharmacy or related science.
• Minimum 5+ years in pharmaceutical or biotechnology industry.
• Experience in providing Drug Product review and release.
• Demonstrated knowledge of GMPs and CFR 210, 211 regulations.
• Ability to make sound, independent quality decisions.
• Excellent verbal and written communication skills.

Responsibilities

• Verify all batches manufactured are compliant with GMPs and CFR 210/211, reviewing records, investigations, non-conformances, and out-of-specifications.
• Provide leadership a summary of findings for any batch not meeting requirements for final disposition.
• Provide batch disposition and release to market with CoA/Conformance.
• Coordinate batch release with Quality Control, Manufacturing and Supply Chain.
• Communicate batch release status externally to partners and answer questions promptly.
• Coordinate activities for batch release and close investigations and events.
• Oversee quality system processes such as Change Control.
• Duties may include writing Annual Product Reviews and supporting audits and CAPA.

Skills

GMP knowledge

Regulatory compliance

Quality decision making

Verbal and written communication

Education

BS degree in chemistry/biochemistry/pharmacy or related science

ASQ Certification preferred

Job description

Aquestive Therapeutics, Inc. in Portage, IN is seeking a Quality Assurance professional to ensure GMP compliance and regulatory adherence during manufacturing operations.

You will review and release drug product documentation, manage batch disposition, and coordinate with Quality, Manufacturing, and Supply Chain to ensure timely release and accurate investigations. Strong communication and independent decision-making are essential.