Position Overview
We are seeking a Quality Assurance Supervisor to oversee daily quality operations in a manufacturing environment related to personal care. This role will lead a team of three QA professionals while ensuring product quality, regulatory compliance, and adherence to established quality systems.
The ideal candidate brings experience in regulated manufacturing, strong knowledge of cGMPs and FDA requirements, and the ability to lead a team while remaining hands‑on with quality investigations, documentation, audits, and continuous improvement initiatives. This individual will partner closely with cross‑functional teams to resolve quality issues, maintain audit readiness, and support the consistent production of safe, high‑quality products.
Key Responsibilities
- Supervise, coach, and develop a team of three Quality Assurance Technicians and/or Inspectors while overseeing daily QA operations.
- Serve as the primary escalation point and subject matter expert for quality, compliance, regulatory, and product‑related issues.
- Ensure compliance with applicable FDA regulations, cGMPs, standard operating procedures (SOPs), product specifications, and internal quality standards.
- Review batch records and manufacturing documentation for accuracy, completeness, and compliance.
- Oversee quality inspections of raw materials, packaging components, labels, in-process materials, and finished products.
- Lead investigations into deviations, customer complaints, and nonconforming materials, including root cause analysis and corrective and preventive actions (CAPA).
- Ensure CAPAs are appropriately implemented and evaluated for effectiveness.
- Participate in internal, FDA, ISO, and customer audits, supporting audit readiness and timely resolution of findings.
- Support equipment and process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), as applicable.
- Develop, maintain, and improve QA procedures, work instructions, and quality programs.
- Ensure employees receive appropriate training on GMPs, quality systems, procedures, and applicable regulatory requirements.
- Collaborate with Manufacturing, Engineering, Supply Chain, and other cross‑functional teams to investigate and resolve quality issues.
- Monitor quality metrics and trends to identify risks, prevent recurring issues, and improve performance.
- Lead continuous improvement initiatives focused on product quality, regulatory compliance, operational efficiency, and risk reduction.
Qualifications
- Bachelor’s degree in Science, Quality, Engineering, or a related field.
- 5+ years of Quality Assurance experience, preferably in regulated manufacturing.
- Experience leading, supervising, coaching, or developing team members.
- Experience in cosmetics, personal care, skincare, pharmaceutical, OTC drug, or a related regulated manufacturing environment preferred.
- Experience supporting or participating in FDA and/or ISO audits.
- Working knowledge of cGMPs, quality management systems, deviations, CAPA, and root cause investigations.
- Experience with quality documentation, internal audits, and continuous improvement initiatives.
- Strong written and verbal communication, interpersonal, and problem‑solving skills.
- Excellent attention to detail, organization, and follow-through.
- Ability to exercise independent judgment, make sound decisions, and elevate quality risks appropriately.
- Six Sigma Green Belt certification preferred, but not required.
What Success Looks Like
- An effective, well‑trained QA team with clear accountability and consistent execution of quality procedures.
- Strong audit readiness and compliance with applicable regulatory requirements.
- Thorough, timely investigations and effective CAPA implementation.
- Proactive identification and resolution of quality risks.
- Strong cross‑functional partnerships that support product quality, customer satisfaction, and continuous improvement.