Senior Quality Associate

Aquestive Therapeutics; Portage (IN); On-site; USD 95,000 - 135,000; Full time

Job summary

Aquestive Therapeutics is seeking a Quality professional to ensure compliance with GMPs and CFR 210/211 for pharmaceutical manufacturing and release. The role involves reviewing documentation, leading batch disposition, and coordinating with Quality Control, Manufacturing and Supply Chain to ensure timely release.

Responsibilities include maintaining the quality system, managing Change Control, CAPA and investigations, and supporting audits.

Qualifications

• Candidates must have strong knowledge of GMPs and CFR 210/211 for pharmaceutical manufacturing, testing and release.
• Ability to make sound, independent quality decisions and ensure compliance with regulations.
• Experience with batch review, release and related quality documentation is preferred.

Responsibilities

• Verify that all batches meet GMP and regulatory requirements by reviewing manufacturing and testing records.
• Provide leadership summaries for batches not meeting standards and support final disposition decisions.
• Coordinate batch release with Quality Control, Manufacturing, and Supply Chain.
• Communicate batch release statuses to external partners and respond to questions promptly.
• Oversee quality system processes (e.g., Change Control) and contribute to CAPA, investigations and audits.

Skills

Quality mindset

Multi-tasking

Excellent communication

Independent decision making

Education

BS degree in chemistry/biochemistry/pharmacy or related field

ASQ Certification preferred

Job description

Job Summary:

This position is responsible for ensuring compliance with pharmaceutical industry regulations and standards as well as company policies and procedures. This position is responsible for performing quality functions not limited to the manufacturing, review and approval of quality related documentation and ensuring compliance during manufacturing operations.

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.
• 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, writing Annual Product Reviews, Events/Deviations/Investigations, evaluating effective CAPA, Product Complaints/Adverse Events, 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.

Qualifications:

• BS degree preferred (in chemistry, biochemistry, pharmacy or related science field)
• Minimum 5+ years-experience in pharmaceutical or biotechnology industry preferred.
• 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
• ASQ Certification preferred.
• 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.

The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended as an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary.

As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing.

Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.