Quality Assurance Specialist / Senior Specialist

Job overview

The Quality Assurance Specialist / Senior Specialist is an onsite, full-time role in Manchester, NH. Compensation is not specified. The role supports the Quality department at the Advanced Regenerative Manufacturing Institute (ARMI)/BioFabUSA. The position exists to support quality systems and compliance during development and manufacture of complex biologic products. It contributes by maintaining procedures and records, reviewing technical and batch documentation, investigating quality events, training personnel, and helping ensure readiness for audits and regulatory inspections.

What you'll do

• Identify and implement quality system improvements
• develop, review, and approve quality system SOPs
• review technical data supporting GLP/GMP operations
• execute and track deviations, CAPAs, risk assessments, and change controls
• participate in root cause investigations
• develop training programs
• review and approve master batch records
• own document control and issuance
• perform manufacturing line clearances
• support audit and inspection readiness
• collaborate on technical transfers.

What we're looking for

Skills & competencies

quality assurance specialist

senior specialist

full-time

manchester nh

armi biofabusa

quality systems

gmp

glp

biologic products

capa

fda regulations

audit readiness

Work arrangement

• Weekend coverage required

Why this role

Requires a bachelor’s degree in life sciences or engineering and at least two years of direct GMP biotech or pharmaceutical quality experience; knowledge of FDA regulations, especially 21 CFR Parts 210 and 211.

About the employer

Advanced Regenerative Manufacturing Institute Inc is hiring for this role. Industry: Professional and Management Development Training. Sector: 61.