QA Supervisor - 2nd Shift

Role Summary

The Quality 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. This is a 2nd Shift role, Monday - Friday, 3pm - 11pm.

Responsibilities

• 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 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.

Qualifications

• 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.

Skills

• Quality assurance
• Regulatory compliance (FDA, cGMP)
• Document control
• Auditing and risk assessment
• Leadership and coaching
• Communication and collaboration

Education

• Bachelor’s degree in a scientific discipline preferred