QA Supervisor – 1st
Perrigo Company plc
full-time
Posted on:
Location Type: Office
Location: Allegan • Missouri • 🇺🇸 United States
Visit company websiteJob Level
Mid-LevelSenior
About 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.
- 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.
- 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.
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
cGMPFDA standardsrisk assessmentquality assuranceauditingrelease methodscorrective actionSOPsSWIsSAP
Soft skills
oral communicationwritten communicationinterpersonal skillsleadershipmentoringcoachingperformance evaluationorganizational skillsproblem-solvingadaptability