Quality Manager at Hunter Recruiting Quality Manager at Hunter Recruiting in East Canton, Ohio Posted in about 20 hours ago.

Type:

full-time The Quality Manager prevents contamination risks to OTC drug and cosmetic products through hygienic design, cleaning and sanitization effectiveness, contamination investigations, and risk-based manufacturing controls. The Quality Manager will manage processes and work cross-functionally with stakeholders and operations teams.

Quality Manager 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 Manager 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 (preferably FDA-regulated) OTC drug, cosmetic, pharmaceutical, food, or medical device experience Direct contamination investigation experience Hygienic equipment design (Preferred) Supplier quality (Preferred) FDA inspection (Preferred)