QA Supervisor
Perrigo Company plc
3 hours ago
On-site
Allegan, MI
Operations
Description Overview
- 1st shift role; Monday–Friday. Weekend coverage may be required on a on-call basis.
Scope of the Role
- Develop and maintain auditing/testing methods to ensure identity and control of packaging materials, including approval of components for production.
- Review/approve controlled documents: SOPs, SWIs (Standard Work Instructions), Job Aids, SCRF (SAP Change Request Form), Rework (RW) notifications, planned deviations, and supplier advisories.
- Coordinate initial response activities including risk assessments.
- Lead/own investigations for packaging incoming out-of-specification and deviation events; identify nonconformances/variances and recommend corrective actions; ensure follow-up with staff/management.
- Manage and train non-exempt staff to ensure documentation meets cGMP and FDA standards.
- Assist with FDA inspections and maintain FDA readiness in Operations; assist with third-party audits (Customer/Contract).
- Select, mentor, and evaluate staff; provide quality coaching and guidance to floor-level operations.
- Manage day-to-day workload, shifting priorities, and initiate/execute/oversee projects as required.
Experience Required
- Bachelor’s degree in a scientific discipline strongly preferred; alternatively, non-degreed with substantial QA or regulated manufacturing/packaging knowledge.
- 4+ years in a Quality role, preferably with leadership responsibilities.
- Exceptional people management; prior people leader experience strongly preferred.
- Strong oral/written communication and interpersonal skills.
- Previous FDA-regulated industry experience preferred; knowledge of product quality and/or manufacturing/packaging processes.
- Leadership/supervisory experience highly preferred.
- Ability to interpret/apply regulations to product quality and processes.
- Familiarity with cGMP, QA, release methods, auditing and/or risk assessment in an FDA-regulated environment highly preferred.
- SAP knowledge preferred.
Benefits
- Competitive compensation; benefits for you and your family; career development opportunities; Total Rewards information.
Application Instructions
- Click the APPLY button to submit an application; SAVE only saves profile.
- Submit all application materials (resumes/CVs) in English.
- 1st shift role; Monday–Friday. Weekend coverage may be required on a on-call basis.
Scope of the Role
- Develop and maintain auditing/testing methods to ensure identity and control of packaging materials, including approval of components for production.
- Review/approve controlled documents: SOPs, SWIs (Standard Work Instructions), Job Aids, SCRF (SAP Change Request Form), Rework (RW) notifications, planned deviations, and supplier advisories.
- Coordinate initial response activities including risk assessments.
- Lead/own investigations for packaging incoming out-of-specification and deviation events; identify nonconformances/variances and recommend corrective actions; ensure follow-up with staff/management.
- Manage and train non-exempt staff to ensure documentation meets cGMP and FDA standards.
- Assist with FDA inspections and maintain FDA readiness in Operations; assist with third-party audits (Customer/Contract).
- Select, mentor, and evaluate staff; provide quality coaching and guidance to floor-level operations.
- Manage day-to-day workload, shifting priorities, and initiate/execute/oversee projects as required.
Experience Required
- Bachelor’s degree in a scientific discipline strongly preferred; alternatively, non-degreed with substantial QA or regulated manufacturing/packaging knowledge.
- 4+ years in a Quality role, preferably with leadership responsibilities.
- Exceptional people management; prior people leader experience strongly preferred.
- Strong oral/written communication and interpersonal skills.
- Previous FDA-regulated industry experience preferred; knowledge of product quality and/or manufacturing/packaging processes.
- Leadership/supervisory experience highly preferred.
- Ability to interpret/apply regulations to product quality and processes.
- Familiarity with cGMP, QA, release methods, auditing and/or risk assessment in an FDA-regulated environment highly preferred.
- SAP knowledge preferred.
Benefits
- Competitive compensation; benefits for you and your family; career development opportunities; Total Rewards information.
Application Instructions
- Click the APPLY button to submit an application; SAVE only saves profile.
- Submit all application materials (resumes/CVs) in English.