Search open positions
Back to results
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:
Hunter International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, gender identity, and gender expression), national origin, age, disability, genetic information, veteran status, or any other status protected by applicable federal, state, or local law. We comply with all applicable equal employment opportunity and affirmative action regulations.
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
- 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)
#INDKC
Hunter International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, gender identity, and gender expression), national origin, age, disability, genetic information, veteran status, or any other status protected by applicable federal, state, or local law. We comply with all applicable equal employment opportunity and affirmative action regulations.
