Manufacturing Quality Supervisor at Aquestive Therapeutics

This role provides quality oversight to production, ensuring the product is manufactured in a safe and compliant manner while meeting company goals. The supervisor demonstrates technical knowledge and will contribute to the overall manufacturing operation.

• Manage the Manufacturing Quality Team across a three-shift operation, including performance management of team and balancing of workload, ensuring work is distributed appropriately and completed correctly in a timely manner to meet company goals.
• Ensure training compliance for the Manufacturing Quality Team along with ensuring appropriate training curriculum is utilized, including but not limited to development and management of OJTS.
• Provide the quality direction and oversight of the event/deviation/capa process for those discovered during/impacting the manufacturing operations, which includes but is not limited to: providing guidance, containment/correction measures, assessing risk, investigating issues, authoring documentation summarizing the event, etc.
• Act as a Manufacturing Quality Team member to perform facility walkthroughs, conduct line clearances, conduct risk mitigation, review batch records and testing data, perform AQL or other sampling, as necessary.
• Act as a backup for back record issuance.
• Author and/or review Forms, Work Instructions, SOPs, Protocols for use in Production for new or existing products.
• Ensures the Pest Control Program is maintained per internal SOPs.
• Ensures the QA Retain Program is maintained per internal SOPs.
• Ensures tasks assigned to Manufacturing Quality for Product Quality Complaints are conducted in a timely manner.
• Provide support in an active role in agency/partner/internal audits, as required.

Qualifications: 

• BS degree preferably in chemistry, biochemistry, pharmacy or related science field
• Minimum 5+ years-experience in a regulated manufacturing environment (pharmaceutical or biotechnology industry preferred).
• Some previous experience with supervision of direct reports or experience in a lead type position preferred.
• Demonstrated knowledge of GMPs and other regulatory requirements for the manufacture of pharmaceutical products under 21 CFR Part 210/211
• Ability to make sound, independent quality decisions after appropriate evaluation.
• Demonstrates high levels of values and integrity.
• Excellent organizational skills, with comfort working in both an electronic and paper system.
• 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 which can be applied both internally and externally.
• ASQ Certification preferred.

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 to be 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.  Please Note:  Aquestive is a drug-free workplace and has a drug free workplace policy in place.

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.