We are hiring a Quality Assurance Supervisor to support site-level compliance with USP standards, FDA pharmaceutical regulations, current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and internal quality systems.
This role provides day-to-day leadership for laboratory operations, quality systems, and regulatory compliance. The ideal candidate has experience working in a pharmaceutical, nutraceutical, OTC drug, API, or other FDA-regulated manufacturing environment and understands the regulatory expectations surrounding USP-compliant products.
Key Responsibilities
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Ensure compliance with USP standards, FDA regulations, cGMP, GLP, and customer requirements.
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Oversee USP laboratory testing, product release, COA review, equipment calibration, and validation activities.
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Lead investigations, root cause analysis, CAPA, and quality trend reporting.
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Support FDA inspections, regulatory audits, and customer audits.
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Develop and maintain USP-related SOPs, work instructions, and quality documentation.
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Supervise and schedule USP Technicians and coordinate testing with operations.
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Promote a culture of quality, compliance, and continuous improvement.
Required
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Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, Food Science, or a related science field.
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2+ years of quality experience in pharmaceutical, OTC drug, nutraceutical, API, or other FDA-regulated manufacturing environments.
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Strong knowledge of USP standards, FDA 21 CFR Parts 210 & 211, cGMP, GLP, CAPA, validation, and quality systems.
Preferred
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Supervisory experience.
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Experience with FDA inspections, ICH guidelines, and validation programs.
