Job description
GMP Quality Specialist
Greater Akron – Canton
$101k – $139K The GMP Quality Specialist prevents contamination risks to OTC drug and cosmetic products through hygienic design, cleaning and sanitization effectiveness, contamination investigations, and risk-based manufacturing controls.
GMP 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
GMP 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 manufacturing company (preferred 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)
