Quality Assurance Supervisor

Quality Supervisor Role:

Maintain the highest standards of operational quality, compliance, and efficiency within our cold storage fulfillment facility.

Oversight of quality control processes, adherence to cGMP and company standards, and collaboration with operations teams for continuous improvement initiatives.

Critical role in upholding quality assurance protocols and ensuring that fulfillment operations meet performance and compliance expectations.

Responsibilities:

• Supervise and enforce quality control procedures throughout fulfillment and cold storage operations.
• Ensure compliance with industry regulations, internal policies, and safety standards.
• Conduct routine inspections and audits of inbound and outbound shipments, storage areas, and handling processes.
• Maintain and oversee proper documentation and record-keeping for audits, inspections, and compliance reporting based on 21 CFR 210 & 211 standards.
• Monitor and validate temperature-controlled environments for proper storage conditions.
• Investigate and report any deviations in temperature protocols and work with operations to take corrective actions.
• Develop and implement standard operating procedures (SOPs) for quality control and assurance.
• Provide training and coaching to warehouse associates on proper handling procedures and quality standards.
• Collaborate with the Operations and Maintenance teams to drive continuous improvement initiatives to enhance quality and minimize errors.
• Investigate and document quality issues, non-conformances, and corrective actions.
• Implement root cause analysis (RCA) and corrective action plans (CAPA) to mitigate risks and prevent recurring issues.
• Serve as the point of contact for internal and external audits, ensuring prompt resolution of any compliance concerns.
• Partner with the warehouse, inventory, and fulfillment teams to maintain quality standards throughout all processes.
• Support maintenance teams in ensuring equipment and facility compliance with safety and operational standards.
• Work closely with leadership to develop quality performance metrics and track key performance indicators (KPIs).

Requirements:

• Strong knowledge of quality assurance, compliance, and operational best practices.
• Detail-oriented, with a problem-solving mindset to identify risks and implement corrective actions.
• Thrives in a fast-paced, high-volume fulfillment environment and can manage multiple priorities efficiently.
• Excellent communication skills, able to collaborate with operations, maintenance, and compliance teams effectively.
• Proficient in quality management systems (QMS), audit processes, and regulatory documentation, specifically in cGMP compliance and 21 CFR 210 & 211.
• Demonstrates leadership qualities, mentoring and training teams to uphold quality standards.
• 3 years of experience in quality assurance, compliance, or operational quality roles, preferably in a cold storage, fulfillment, or warehouse environment.
• Experience conducting internal audits, inspections, and implementing quality control measures.
• Strong analytical skills and the ability to conduct root cause analysis and develop corrective action plans.
• Proficiency in Microsoft Office Suite, warehouse management systems (WMS), and quality management software.
• Ability to train and educate teams on compliance standards and best practices.

Nice to Have:

• Certifications in ISO 9001, Lean Six Sigma, or related quality assurance fields.
• Experience working in multi-temperature warehouses (-90°C to ambient temperatures).
• Knowledge of continuous improvement methodologies.

Physical Demands & Working Conditions:

• Must be able to work in extremely cold storage environments (-90°C to 20°C) for extended periods.
• Ability to lift up to 50 lbs. occasionally and withstand constant physical activity (standing, walking, bending, stooping).
• Willingness to work flexible hours, including nights, weekends, and overtime as needed.
• Exposure to heavy machinery, conveyors, and changing environmental conditions.
• Must follow strict safety and operational protocols to ensure compliance and efficiency.