Manufacturing Quality Supervisor

Aquestive Therapeutics•Portage, IN

About The Position

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.

Requirements

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

Nice To Haves

ASQ Certification preferred.

Responsibilities

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.