PVT Chemistry Lab Supervisor - 1st Shift - United States
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Perrigo Nutritionals is the largest supplier of store-brand infant formula in the world with distribution to leading retailers. The Vermont facility is the only ISO 9001 certified infant formula manufacturing facility in the United States.
Perrigo Nutritionals, located in Georgia, VT, has an opening for a Quality Assurance Supervisor. The QA Supervisor ensures company products meet defined quality standards and are manufactured in compliance with cGMP through supervision of product auditing, product release processes and quality assurance staff. The QA Supervisor 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. The individual in this role 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). Ensuring compliance for meeting all internal and external customer product release on all MBRs reviews and releases and coordinating initial response activity including risk assessment and containment for Quality Events are also primary responsibilities in this role.
Other responsibilities include, but are not limited to:
- 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 documentation. Also, assists with 3rd party Audits (Customer, Contract).
- Selects, mentors, and evaluates performance of non exempt staff and provides quality coaching and guidance to QA Release staff.
- Manages shifting priorities to support internal & external customers and initiates, executes and oversees various projects as required.
- Bachelor’s degree, within a scientific discipline 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 pharmaceutical environment.
- Ability to review, release and interpret MBR’s against product materials for customer release and produce C of A / C of C for released products.
- Ability to provide metrics for QA Document Release of all PMH Batch Records.
- Previous experience ensuring the quality of products and or manufacturing/packaging processes.
- Previous leadership experience highly preferred.
- Ability to interpret and apply formal regulations to product quality and processes.
- Previous experience working in an FDA regulated industry preferred.
- Familiarity with cGMP, quality assurance, release methods, auditing and/or risk assessment in an FDA regulated environment highly preferred.
- Knowledge of SAP preferred.
- Good oral and written communication skills and excellent interpersonal skills.
An Equal Opportunity Employer - M/F/D/V
Internal applicants can apply by end of day April 12, 2017 to be considered.
Internal applicants' direct supervisor and senior management will be notified by the talent acquisition team upon candidacy.