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Aquestive Therapeutics · 1 day ago

Senior Quality Associate

Portage, IN

Full-time

Onsite

Senior Level

5+ years exp

Aquestive Therapeutics is focused on ensuring compliance with pharmaceutical industry regulations and standards. The Senior Quality Associate will lead and mentor within the quality organization, verifying batch compliance and managing internal processes for batch release.

Pharmaceutical

Responsibilities

Responsible for verifying all batches manufactured are compliant with Good Manufacturing Practices 21 CFR 210 and 211, product registration/marketing authorization and all other requirements by reviewing manufacturing and laboratory testing records, investigations, non-conformances and out-of-specifications and analyzing cumulatively

Provides Quality leadership a summary of findings for any batch that does not meet standard requirements for final disposition

Provide batch disposition and subsequent release to market and/or marketing authorization holder, and issuance of Certificate of Analysis/Conformance according to country specific requirements

Manages internal process for batch release, working closely with Quality Control, Manufacturing and Supply Chain

Responsible for communicating batch release status externally to partners, triaging questions and organizing the provision of, and providing responses in a timely manner

Coordinate activities associated with batch release, ensuring corrections are completed and associated batch documentation and investigations and events are closed out

Compiles and documents monthly metrics, quarterly reports, and ad-hoc reports and data analysis of reports

Provide inputs to process validation activities and process risk decisions (PVMP/PFMEA)

Review, consult, and approve validations and equipment/instrument qualifications (IQ, OQ, PQ, etc.)

Author, review and approve risk assessments

Act as a quality representative on internal product teams, including development of products

Oversee quality system functional processes, such as Change Control

Will be assigned duties and responsibilities within the Quality System/Unit; specific duties will depend on the assignment and experience of the individual and may include any of the following: coordination/evaluation for Change Control, reviewing Annual Product Reviews, review and approval of validation documents, Events/Deviations/Investigations, evaluating effective CAPA, Product Complaints/Adverse Events, Labeling, Supplier Quality, authoring review and/or approval of standard Quality System documentation (SOPs, Forms, reports, etc.), conducting risk assessments, providing agency and partner audit support, etc

Qualification

GMP knowledgeCFR 210211 knowledgePharmaceutical industry experienceASQ CertificationMulti-tasking abilityValuesCommunication skillsIntegrity

Required

BS degree preferably in chemistry, biochemistry, pharmacy or related science field

Minimum 5+ years-experience in pharmaceutical or biotechnology industry required

Previous experience in providing pharmaceutical Drug Product review and release

Demonstrated knowledge of GMPs and other regulatory requirements for the manufacture, testing, and release of pharmaceutical

Knowledge and understanding of CFR 210, 211 regulations and ability to apply

Ability to make sound, independent quality decisions

Demonstrates high levels of values and integrity

Ability to easily multi-task, prioritize and adapt to changing business needs, as well as recognize opportunities for continuous improvement and be a champion of change

Excellent verbal and written communication skills both internally and externally