Quality Supervisor
About the role
We are seeking a Quality Supervisor to serve as the critical gatekeeper for our Raw Material Warehouse and Sampling Suite. This role requires a dynamic floor leadership position designed for an analytical, proactive supervisor who understands cGMP cleanroom protocols and documentation integrity.
Responsibilities
Directly manage the daily compliance, environment, and personnel footprint inside our specialized raw materials sampling suite.
Balance hands-on material validation with rigorous quality systems governance.
Plan & Allocate Floor Manpower: Design daily schedules and balance workloads based on shifting operational and client priorities. Assign frontline associates to specialized suite functions including cleanroom gowning, material checks, and environmental monitoring based on their technical skills.
Govern the cGMP Sampling Environment: Maintain absolute control over the Raw Material Sample Suite. Oversee precise cleanroom workflows, trafficking patterns, rigorous cleaning schedules, and contamination control procedures to safeguard product integrity.
Execute Material Quality Control: Physically inspect incoming raw material lots for hidden damage or discrepancies. Empower your team to confidently accept or reject batches using specialized inventory systems and analytical tools (such as LIMS, Raman spectroscopy, calipers, and gauges) to verify client specifications.
Drive Quality Systems & Sourcing: Own, document, and advance critical quality system processes including deviations, change controls, and thorough root-cause investigations. Cross-train floor associates to ensure high-accuracy document retention and data integrity.
Host External & Regulatory Audits: Serve as the primary quality contact and technical anchor for internal reviews, major client inspections, and strict regulatory audits (including FDA, DHS, and OSHA). Ensure all quality records are maintained in an organized, instantly retrievable layout.
Requirements & Core Qualifications
Education: Bachelor’s degree in a scientific or technical discipline (e.g., Biology, Chemistry, Pharmaceutical Sciences) or equivalent professional industry experience.
Experience: Minimum 3 years of hands-on Quality experience in a strict, cGMP-regulated environment (Pharma, Biotech, or Medical Devices).
Leadership: Previous supervisory or managerial experience is required. Proven ability to coach, cross-train, and manage headcount, schedules, and absenteeism.
Regulatory Knowledge: Deep understanding of current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP), and Good Documentation Practices (GDocs) as they apply to raw materials handling, FDA, and Department of Homeland Security (DHS) frameworks.
Systems & Analytics: Computer literate (Microsoft Office Suite) with the analytical capacity to review complex quality data records, evaluate operational risks, and implement compliant solutions quickly.
Physical Demands & Work Environment
Physical movements include bending, stooping, and lifting to 50 pounds as part of daily work routine.
Work is performed in a warehouse environment subject to temperature variances.
Disclaimer
This job description is not intended to be all-inclusive. This position may be required to perform other related duties assigned to meet the ongoing needs of the organization.