Quality Operations Supervisor (2nd Shift)
Summary
Oversee daily quality operations in a pharmaceutical/healthcare setting, ensuring compliance with FDA, DEA, and cGMP standards while leading a team of quality staff.
At Safecor Health, our values of Care, Commitment, and Excellence guide everything we do. We care about the patients and healthcare providers who rely on us, we are committed to maintaining the highest standards of quality and compliance, and we pursue excellence in every detail of our operations.
We are seeking a Quality Supervisor to provide leadership, oversight, and guidance across Safecor Health’s quality functions. This role bridges quality assurance and operations, ensuring compliance with FDA, DEA, and cGMP requirements while fostering a culture of accountability, teamwork, and continuous improvement.
Job Summary
The Quality Supervisor is responsible for overseeing day-to-day quality operations, including in-process and final product inspections, deviation and audit management, and controlled substance documentation. This role will lead, coach, and develop quality staff, while also working cross-functionally with operations to ensure that all production processes meet regulatory and company standards.
Key Responsibilities
Leadership & Supervision
- Provide daily direction, coaching, and feedback to quality staff, fostering professional growth and accountability.
- Train and mentor new employees on quality procedures, compliance, and best practices.
- Promote a safe, compliant, and inclusive environment, ensuring adherence to OSHA and company safety requirements.
Quality Assurance & Compliance
- Oversee in-process and final inspections to ensure products meet quality specifications and cGMP requirements.
- Manage deviations, incident reports, and audits - including investigation, documentation, and closure.
- Ensure accurate documentation and recordkeeping for all controlled substances, DEA 222 forms, ARCOS reporting, and product destruction activities.
- Support regulatory inspections and customer audits with professionalism and thorough preparation.
- Ensure labeling accuracy and oversee creation and revision of drug and packaging labels.
Cross-Functional Collaboration
- Partner with operations supervisors and pharmacists to align on production and quality goals.
- Work closely with operations to ensure inspection procedures are implemented, documented, and maintained.
- Serve as a point of contact for drug manufacturers to gather product-specific information.
- Facilitate clear, timely, and concise communication across teams and with customers.