Quality Unit Lead — Pharma & Medical Device Compliance

Keystone Industries; Gibbstown (NJ); On-site; USD 70,000 - 90,000; Full time

Job summary

Keystone Industries is seeking an Assistant Quality Unit Manager in Gibbstown, NJ. This role focuses on overseeing activities to ensure product quality within manufacturing, requiring a minimum of 5 years of relevant experience. The ideal candidate will have expertise in FDA regulations (CFR 210, 211, 820) and a Bachelor’s Degree in a related field. Competitive salary offered ranges from $70,000 to $90,000. This position supports a quality-focused approach within a dynamic environment.

Qualifications

• Minimum 5 years’ directly related experience.
• Experience in pharmaceutical industry or manufacturing Quality Control.
• Strong attention to detail and ability to perform under deadlines.

Responsibilities

• Coordinate activities to control manufacturing quality.
• Provide oversight for inspection activity of cosmetic and pharmaceutical products.
• Participate in audits and inspections.

Skills

Knowledge of FDA CFR 210 & 211

Knowledge of FDA CFR 820 / ISO 13485

Leadership skills

Exceptional computer skills

Attention to detail

Education

Bachelor’s Degree in Technical/Science/Chemistry

Tools

Microsoft Office Suite

ERP/MRP software

Job description

Keystone Industries is seeking an Assistant Quality Unit Manager in Gibbstown, NJ. This role focuses on overseeing activities to ensure product quality within manufacturing, requiring a minimum of 5 years of relevant experience. The ideal candidate will have expertise in FDA regulations (CFR 210, 211, 820) and a Bachelor’s Degree in a related field. Competitive salary offered ranges from $70,000 to $90,000. This position supports a quality-focused approach within a dynamic environment.