Senior Quality Specialist — Operational Area

Job overview

The Senior Quality Specialist role is onsite in Boston, MA. Compensation is not specified. The position provides quality assurance support for manufacturing operations, analytical laboratory operations, and materials management for external manufacturing programs at VCGT. The specialist reviews batch and quality-system documentation to support product disposition and release. Through documentation review, audit readiness, quality metrics, and escalation of significant findings, the role helps maintain quality oversight across external manufacturing programs.

What you'll do

• Review executed batch records and critical systems documentation
• determine acceptability using standard operating procedures
• verify required documentation before product or system release
• support batch release management
• assist with audit preparation and participate in audits and inspections as needed
• maintain retrievable files
• support quality-system metrics and reporting
• escalate critical and major findings and monitor KPIs with Quality Systems and GxP operational areas.

What we're looking for

Skills & competencies

senior quality specialist

boston ma

quality assurance

gmp

batch records

batch release

external manufacturing

quality audits

capa

root cause analysis

cell and gene therapy

Work arrangement

• Weekend coverage required

Why this role

Experience with GMP manufacturing quality assurance, event investigations, root cause analysis, and CAPA is sought; cell or gene therapy QA experience and aseptic processing knowledge are noted.

About the employer

Katalyst Healthcares & Life Sciences is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.