QA Supervisor - 1st

Perrigo • Allegan Township, MI

1d

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.Description Overview 
The Quality Assurance Supervisor reports to the QA Manager and primarily works to develop and maintain auditing methods which ensure identity control in raw materials, packaging, manufacturing and finished goods, with approval of final release of product for shipment.
 Please note: This is a 1st Shift role, Monday - Friday. Scope of the Role 
• Reviews and approves controlled documents which includes but is not limited to the following: SOPs, SWIs (Standard Work Instructions), Job Aids, SCRF (SAP Change Request Form), SBRF (Split Batch Request Form), RW’s (Rework) Notifications, planned deviations and supplier advisories. • Coordinates initial response activity including risk assessment and containment for Quality 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• 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 3rd party Audits (Customer, Contract). • Selects, mentors, and evaluates performance of non exempt staff and provides quality coaching and guidance to floor level operations. • Manages day to day work load of non exempt staff and manages shifting priorities to support internal & external customers.• Executes and oversees projects as required.

Requirements

• Bachelor’s degree within a scientific discipline is strongly preferred. Consideration may be given to non-degreed candidates who meet all other qualifications, possess considerable quality assurance or manufacturing and packaging process knowledge in a regulated environment, and are currently in active pursuit of a degree.
• 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

• Reviews and approves controlled documents which includes but is not limited to the following: SOPs, SWIs (Standard Work Instructions), Job Aids, SCRF (SAP Change Request Form), SBRF (Split Batch Request Form), RW’s (Rework) Notifications, planned deviations and supplier advisories.
• Coordinates initial response activity including risk assessment and containment for Quality 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
• 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 3rd party Audits (Customer, Contract).
• Selects, mentors, and evaluates performance of non exempt staff and provides quality coaching and guidance to floor level operations.
• Manages day to day work load of non exempt staff and manages shifting priorities to support internal & external customers.
• Executes and oversees projects as required.

Benefits

• We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level