Senior Quality Assurance Specialist, GMP Biotech

Advanced Regenerative Manufacturing Institute (ARMI) | BioFabUSA; Manchester (NH); On-site; USD 85,000 - 110,000; Full time

Job summary

Advanced Regenerative Manufacturing Institute (ARMI) | BioFabUSA is seeking Quality Assurance Specialists/Senior Specialists to support quality system initiatives and ensure compliance during development and manufacture of complex biologic products.

You will report to the Director of Quality, advance SOPs, manage deviations and CAPAs, and prepare for audits. A Bachelor’s in life sciences or engineering and 2+ years of GMP biotech quality experience are required.

Qualifications

• Bachelor of Science degree in life sciences or engineering.
• Minimum of 2+ years of direct GMP biotech/pharmaceutical Quality experience.
• Knowledge of FDA regulations, especially 21 CFR Part 210 and 211.
• Excellent written and verbal communication; collaborative team player.
• Experience in the CDMO business model is desired.

Responsibilities

• Be a champion for continuous improvement and identify and implement solutions to enhance quality system effectiveness.
• Develop, review, and approve Quality System SOPs.
• Review technical data in support of GLP/GMP operations.
• Execute and track Quality System Events (e.g., deviations, CAPAs, risk assessments, and change controls).
• Participate in root cause analyses to identify, mitigate, and prevent nonconformances.
• Prepare engaging programs to train ARMI personnel.
• Review and approve master batch records for GMP Tissue Foundry processes.
• Own the document control and issuance processes.
• Perform line clearances of manufacturing spaces.
• Ensure site readiness for audits and regulatory inspections.
• Collaborate with Tech Team, Program Management, and external stakeholders to facilitate technical transfer of incoming projects.

Skills

Interpersonal communication

Written communication

Verbal communication

Team collaboration

GMP knowledge

FDA regulations

MS Word

Microsoft Office

Problem solving

Education

Bachelor of Science in life sciences or engineering

Tools

MS Word

Job description

Advanced Regenerative Manufacturing Institute (ARMI) | BioFabUSA is seeking Quality Assurance Specialists/Senior Specialists to support quality system initiatives and ensure compliance during development and manufacture of complex biologic products.

You will report to the Director of Quality, advance SOPs, manage deviations and CAPAs, and prepare for audits. A Bachelor’s in life sciences or engineering and 2+ years of GMP biotech quality experience are required.