Senior Supplier Quality Auditor – GMP

New England Air Systems, LLC; Bedford (NH); On-site; USD 85,000 - 120,000; Full time

Job summary

JobRx, Inc. is seeking a Sr. QA Specialist in Bedford, New Hampshire, to manage supplier quality, ensuring compliance with quality standards. This role involves performing audits, drafting quality agreements, and assisting during regulatory inspections.

Candidates should have 15+ years in a QA GMP environment, excellent communication skills, and knowledge of FDA regulations. The position offers an opportunity to work in a dynamic environment with a focus on continuous improvement.

Qualifications

• 15+ years in a QA GMP environment; alternatively, 10+ years with a Master’s degree; or 20+ years with a High School diploma.
• Experience with GMP quality systems in pharmaceutical, biotech, or medical device environments.
• Thorough knowledge of FDA regulations (21CFR Part 210, 211 & 820) and other relevant regulations.

Responsibilities

• Perform supplier audits to evaluate compliance with quality standards.
• Draft, review, and manage supplier quality assurance agreements.
• Assist during FDA and other regulatory agency inspections.

Skills

Exceptional organizational skills

Excellent interpersonal and communication skills

Proficiency in MS Office (Word, Excel, Access, Visio)

Detail oriented and results-driven

Education

Bachelor of Science degree or equivalent experience

Job description

JobRx, Inc. is seeking a Sr. QA Specialist in Bedford, New Hampshire, to manage supplier quality, ensuring compliance with quality standards. This role involves performing audits, drafting quality agreements, and assisting during regulatory inspections.

Candidates should have 15+ years in a QA GMP environment, excellent communication skills, and knowledge of FDA regulations. The position offers an opportunity to work in a dynamic environment with a focus on continuous improvement.