QA Supervisor

Description Overview

This is a 1st shift role working Monday-Friday. Weekend coverage may be required on an on-call basis.

The QA Supervisor reports to the QA Packaging AD and primarily works to develop and maintain auditing & testing methods which ensure identity & control of packaging materials, with approval of components for use in production.

This position reviews and approves controlled documents, including SOPs, SWIs, Job Aids, SCRF, RW notifications, planned deviations and supplier advisories.

Coordinates initial response activity including risk assessments and direct responsibility for investigations related to packaging incoming out-of-specification and deviation events.

Identifies any non conformances or variances, recommends corrective action, and ensures follow up actions are taken by working with staff and management.

Manages/trains non exempt staff to ensure all documentation meets cGMP and FDA standards. Assists with FDA inspections as requested and ensures FDA readiness in Operations. Also assists with third party audits.

Selects, mentors, evaluates performance of non exempt staff and provides quality coaching and guidance to floor level operations.

Manages day to day workload of non exempt staff and shifting priorities to support internal & external customers, and initiates, executes, and oversees projects as required.

• Bachelor’s degree in a scientific discipline is strongly preferred; consideration may be given to non-degreed candidates with extensive QA or manufacturing and packaging process knowledge.
• Minimum of four (4) years of experience in a Quality role, preferably with leadership responsibilities.
• Exceptional people management abilities are essential; previous people leader experience is strongly preferred.
• Good oral and written communication and excellent interpersonal skills.
• Previous experience in an FDA regulated industry preferred.
• Experience ensuring quality of products and/or manufacturing/packaging processes.
• Previous supervisory experience highly preferred.
• Ability to interpret and apply formal regulations to product quality and processes.
• Familiarity with cGMP, quality assurance, release methods, auditing and risk assessment in an FDA regulated environment highly preferred.
• Knowledge of SAP preferred.

We offer competitive compensation and benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported professionally and personally.

We are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law.