Join a U.S.-based botanical ingredient innovator with over two decades of rooted expertise in extracting science-backed health benefits. Operating out of a 24,000sqft GMP-certified facility with in-house QC/R&D labs, this company leads with high-purity ingredientsdelivering clean, solvent-free bioactives acclaimed for metabolic, cardiovascular, and healthy aging support.
Position Summary
The Quality Assurance Manager leads all site-level quality and food safety operations at the Massachusetts manufacturing facility, producing ingredients through distillation. This role manages the Food Safety Plan, site Quality Management System (QMS), regulatory compliance (21 CFR 111 & 117) , and oversees QA for warehouse, production, and co-manufacturing partners, including supplier approval and FSVP compliance.
Key Responsibilities
Champion a strong culture of quality and food safety across the site.
Serve as PCQI and manage Food Safety & Quality Management Systems, including SOPs, training, and documentation.
Oversee GMP, HACCP, and Food Defense training programs.
Manage validation/verification activities (sanitation, inspections, environmental monitoring).
Lead deviation investigations, CAPAs, complaints, and recalls.
Review and approve production batch records, ensuring regulatory and spec compliance.
Oversee QA in warehouse operations (receiving, sampling, storage).
Manage supplier quality, FSVP compliance, and audits of suppliers/CMOs.
Act as point of contact for FDA, state, customer, and internal audits.
Collaborate with Production, R&D, Lab, and Supply Chain to ensure quality standards.
Track quality metrics, conduct reviews, and drive continuous improvement.
Lead and develop QA team (13 FTEs), fostering a culture of compliance and accountability.
Qualifications
Bachelors in Food Science, Chemistry, Biology, or related (advanced degree preferred).
10+ years of progressive QA experience in food, dietary supplements, or ingredients.
Strong knowledge of 21 CFR 117 ; familiarity with 21 CFR 111 .
PCQI certified with hands-on QA leadership in manufacturing.
Experience with supplier quality and FSVP requirements.
Strong leadership, communication, and documentation skills.
Proficiency in Microsoft Office; project management tools a plus.
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