QA Supervisor

Perrigo•Allegan Township, MI

7d•Onsite

About The Position

At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill®, Compeed®, Solpadeine®, NiQuitin®, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging. Join us on our One Perrigo journey as we evolve to win in self-care.

Requirements

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.

Responsibilities

Develop and maintain auditing & testing methods which ensure identity & control of packaging materials, with approval of components for use in production.
Review and approve controlled documents, including SOPs, SWIs (Standard Work Instructions), Job Aids, SCRF (SAP Change Request Form), RW’s (Rework) Notifications, planned deviations and supplier advisories.
Coordinate initial response activity including risk assessments and direct responsibility for investigations related to packaging incoming out-of-specification and deviation events.
Identify any non conformances or variances, recommend corrective action, and ensure follow up actions are taken by working with staff and management in those areas.
Manage/train non exempt staff to ensure that all documentation meets cGMP and FDA standards.
Assist with FDA inspections as requested and ensure FDA readiness in Operations.
Assist with third party Audits (Customer, Contract).
Select, mentor, and evaluate performance of non exempt staff and provide quality coaching and guidance to floor level operations.
Manage day to day work load of non exempt staff and manage shifting priorities to support internal & external customers.
Initiate, Execute and Oversee projects as required.