GMP Quality Specialist

Quality Specialist Responsibilities: Lead investigations of particulate, foreign material, plant debris, and microbiological contamination events Identify contamination pathways and drive sustainable CAPA Perform risk assessments (FMEA/HACCP) on manufacturing processes, equipment, suppliers, cleaning failures, and facility changes Recommend procedural and supplier corrective actions Perform risk assessments (FMEA/HACCP) on manufacturing processes, equipment, suppliers, cleaning failures, and facility changes Recommend engineering, procedural, and supplier corrective actions Establish site cleanliness standards, performance metrics, and conduct routine audits of operations Assess new and existing equipment and facility design for contamination risks Review pipe velocities, drainability, dead legs, cleanability, and CIP/COP effectiveness Evaluate cleaning and sanitization procedures for effectiveness and GMP compliance Review cleaning validation/verification strategies, swab locations, acceptance criteria, and inspection methods Assess contamination risks from raw materials, packaging, components, and contract manufacturers Support supplier audits and corrective action programs Influence manufacturing, maintenance, engineering, quality, sanitation, and supplier partners to prioritize contamination control and hygienic design actions Provide subject matter expertise and practical recommendations that guide decision‑making, risk reduction, and sustainable corrective actions Build alignment across teams by clearly communicating risks, connecting technical findings to business and compliance impacts, and driving accountability for follow‑through Lead cross‑functional problem‑solving efforts when contamination, cleaning effectiveness, or facility/equipment design concerns require coordinated action

Quality Specialist Requirements: Bachelor's degree required in one of the following technical fields (i.e biology, chemistry, toxicology, pharma, food science) Minimum ten (10) years of experience in a manufacturing company (preferred FDA‑regulated) OTC drug, cosmetic, pharmaceutical, food, or medical device experience