GMP Quality Specialist: Contamination Control Leader

Hunter Recruiting; Canton (OH); On-site; USD 70,000 - 100,000; Full time

Job summary

Hunter Recruiting is seeking a Quality Specialist to prevent contamination risks in OTC drug and cosmetic manufacturing. The role focuses on hygienic design, cleaning and sanitization effectiveness, and risk‑based manufacturing controls.

Responsibilities include leading contamination investigations, identifying pathways, performing FMEA/HACCP risk assessments, and driving CAPA with cross‑functional teams to ensure GMP compliance and robust corrective actions.

Qualifications

• Bachelor's degree in a technical field as listed.
• 10+ years of manufacturing experience, FDA‑regulated preferred.
• Experience with OTC drug, cosmetics, pharma, food, or medical devices.

Responsibilities

• Lead investigations of contamination events including particulates, foreign material, plant debris, and microbiological issues.
• Identify contamination pathways and drive sustainable CAPA actions.
• Perform risk assessments (FMEA/HACCP) on processes, equipment, suppliers, cleaning failures, and facility changes.
• Review cleaning validation/verification strategies, swab locations, acceptance criteria, and inspection methods.
• Influence cross‑functional teams to prioritize contamination control and hygienic design actions.

Skills

Investigations

CAPA

Risk assessment

GMP knowledge

Education

Bachelor's degree in biology/chemistry/toxicology/pharma/food science

Job description

Hunter Recruiting is seeking a Quality Specialist to prevent contamination risks in OTC drug and cosmetic manufacturing. The role focuses on hygienic design, cleaning and sanitization effectiveness, and risk‑based manufacturing controls.

Responsibilities include leading contamination investigations, identifying pathways, performing FMEA/HACCP risk assessments, and driving CAPA with cross‑functional teams to ensure GMP compliance and robust corrective actions.