GMP Quality Lead - Contamination Prevention & Design

Hirecruiting; Akron, Northern (OH, KY); Hybrid; USD 101,000 - 139,000; Full time

Benefits offered by this job

Health insurance

Job summary

Hirecruiting in Greater Akron, OH seeks a GMP Quality Specialist to prevent contamination in OTC drug and cosmetic products through hygienic design, cleaning validation, and risk-based manufacturing controls.

You will lead investigations into particulate, foreign material, and microbiological contaminants, perform risk assessments (FMEA/HACCP), and drive CAPA with cross-functional teams to ensure GMP compliance and robust supplier and facility design.

Qualifications

• Bachelor's degree in biology, chemistry, toxicology, pharma, or food science.
• 10+ years of manufacturing experience in FDA-regulated environments.
• Experience with OTC drug, cosmetic, pharmaceutical, food, or medical device products.
• Direct contamination investigation experience.

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, engineering, and supplier corrective actions.
• Establish site cleanliness standards, performance metrics and conduct routine audits of operations.

Skills

Contamination investigations

Hygienic design

Risk assessment (FMEA/HACCP)

CAPA management

GMP compliance

Cross-functional collaboration

Education

Bachelor's degree in biology/chemistry/pharma

Job description

Hirecruiting in Greater Akron, OH seeks a GMP Quality Specialist to prevent contamination in OTC drug and cosmetic products through hygienic design, cleaning validation, and risk-based manufacturing controls.

You will lead investigations into particulate, foreign material, and microbiological contaminants, perform risk assessments (FMEA/HACCP), and drive CAPA with cross-functional teams to ensure GMP compliance and robust supplier and facility design.