Senior Quality Associate

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.
Portage, IN 46368, USA

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.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.