QA Specialist - Regenerative Biotech GMP & Compliance

Armiusa; Manchester (NH); On-site; USD 85,000 - 125,000; Full time

Job summary

ARMI (Advanced Regenerative Manufacturing Institute) seeks a Quality Assurance Specialist/Senior Specialist to support GMP/GLP operations and drive quality system improvements. You will work under the Director of Quality to ensure regulatory compliance and robust quality processes across development and manufacturing activities.

Candidates should have a life sciences or engineering background, 2+ years GMP biotech quality experience, and familiarity with FDA 21 CFR Part 210 and 211.

Qualifications

• Bachelor of Science in life sciences or engineering.
• Minimum 2+ years GMP biotech/pharmaceutical quality experience.
• Knowledge of FDA regulations, 21 CFR Part 210 and 211.
• Strong written and verbal communication skills.
• Experience in fast-paced, collaborative environments.
• CDMO experience is a plus.

Responsibilities

• Improve quality system effectiveness.
• Develop, review and approve Quality System SOPs.
• Review data for GLP/GMP operations.
• Manage Quality System Events (deviations, CAPAs, risk assessments, change controls).
• Lead root cause investigations to prevent nonconformances.
• Train ARMI personnel on quality processes.
• Review master batch records for GMP Tissue Foundry processes.
• Own document control and issuance processes.
• Prepare site for audits and regulatory inspections.
• Collaborate with teams to transfer projects.

Skills

Interpersonal skills

Effective communication

Team collaboration

Initiative

MS Word

GMP experience

FDA regulations

Education

Bachelor of Science in life sciences or engineering

Job description

ARMI (Advanced Regenerative Manufacturing Institute) seeks a Quality Assurance Specialist/Senior Specialist to support GMP/GLP operations and drive quality system improvements. You will work under the Director of Quality to ensure regulatory compliance and robust quality processes across development and manufacturing activities.

Candidates should have a life sciences or engineering background, 2+ years GMP biotech quality experience, and familiarity with FDA 21 CFR Part 210 and 211.