QA Components Supervisor

Description Overview

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

Scope of the Role

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 (Standard Work Instructions), Job Aids, SCRF (SAP Change Request Form), RW’s (Rework) 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 in those areas.

The incumbent Manages/trains non exempt staff to ensure that 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 (Customer, Contract).  Selects, mentors, and evaluates performance of non exempt staff and provides quality coaching and guidance to floor level operations.  The QA Supervisor Manages day to day work load of non exempt staff and manages shifting priorities to support internal & external customers, and Initiate, Execute and Oversee projects as required.

Experience Required

• Bachelor’s degree, within a scientific discipline is strongly preferred. Consideration may be given to non-degreed candidates who meet all other qualifications and possess considerable quality assurance or manufacturing and packaging process knowledge in a regulated environment. 
• Minimum of four (4) years of experience in a Quality role, preferably with leadership responsibilities.
• Exceptional people management abilities are essential for success in this role; previous people leader experience is strongly preferred.
• Good oral and written communication skills, and excellent interpersonal skills.
• Previous experience working in an FDA regulated industry preferred. 
• Previous experience ensuring the quality of products and or manufacturing/packaging processes.
• Previous leadership/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/or risk assessment in an FDA regulated environment highly preferred.
• Knowledge of SAP preferred.