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Perrigo Company

External Quality Supervisor II

Perrigo Company - Allegan, MI

Job Description

To ensure that company products meet defined quality standards through supervision of product auditing and product release processes and staff.

Major Duties / Responsibilities

% of Time

Develops and maintains auditing methods which ensure identity control in raw materials, packaging, manufacturing and finished goods, with approval of final release of product for shipment.

5%

Reviews and approves controlled documents, including SOPs, SWIs (Standard Work Instructions), Job Aids, SCRF (SAP Change Request Form), SBRF (Split Batch Request Form), RW’s (Rework) Notifications, planned deviations, and ORAF’s (Operational Risk Assessment Form).

10%

Performs risk assessment and containment for Quality Events.

30%

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.

10%

Manages/trains non exempt staff to ensure that all documentation meets cGMP and FDA standards.

10%

Assists with FDA inspections as requested and ensures FDA readiness in Operations. Also, assists with 3

rd

party Audits (Customer, Contract).

5%

Selects, mentors, and evaluates performance of non exempt staff

10%

Manages day to day work load of non exempt staff and manages shifting priorities to support internal & external customers, and Initiate and Executes and oversees projects as required.

20%

Required Experience

Good oral and written communication skills, and excellent interpersonal skills.

Demonstrated ability to interpret and apply FDA regulations relevant to company processes, and a familiarity with quality assurance, release methods, auditing, risk assessment and SAP.

Bachelor’s degree, within a scientific discipline preferred.

Minimum of three years experience working in an FDA regulated industry, including a minimum of one year in a QC/QA role and some previous supervisory experience.

6 days 19 hours ago

Perrigo Company

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External Quality Supervisor II Perrigo Company - Allegan, MI, United States

   

Location: Allegan, MI

Company Profile:
Headquartered in Ireland, Perrigo Company plc is a leading global healthcare supplier that develops, manufactures and distributes over-the-counter (OTC) and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, animal health, dietary supplements, active pharmaceutical ingredients (API), and medical diagnostic products and receives royalties from Multiple Sclerosis drug Tysabri®.