GMP Quality Systems Specialist - Biologics CDMO

Northway Biotech, Inc.; Waltham, Boston (MA, MA); On-site; USD 85,000 - 115,000; Full time

Job summary

Northway Biotech is seeking an experienced Quality Systems Specialist to support GMP Quality Systems at our Waltham, MA site. This role focuses on maintaining regulatory compliance, managing quality documentation, and supporting deviations, CAPAs, change controls, and continuous improvement in a biologics CDMO environment.

The successful candidate will collaborate across Manufacturing, QC, Validation, and Engineering, oversee electronic quality management systems, and ensure timely completion of

Qualifications

• Bachelor's degree in a life sciences field.
• Minimum 3 years of QA/Quality Systems experience in GMP biotech/pharma.
• Strong knowledge of cGMP, FDA requirements, and GMP documentation.
• Experience with deviations, CAPAs, change controls, and document management.
• Experience with electronic Quality Management Systems (eQMS).

Responsibilities

• Maintain Quality Systems and documentation in accordance with cGMP and internal procedures.
• Generate, review, revise, and maintain GMP documents (SOPs, forms, work instructions).
• Support deviations, CAPAs, change controls, and quality investigations.
• Review GMP documentation (specs, methods, validation protocols, tech transfers).
• Coordinate document control activities (issuance, versioning, reviews, archival).
• Monitor Quality System activities and track action completion.
• Assist internal and customer audits and regulatory inspections.
• Prepare data for periodic quality reviews and management reports.
• Maintain and support eQMS and training documentation.
• Collaborate with Manufacturing, QC, Validation, Engineering for compliance.

Skills

Quality Systems

Deviations handling

CAPAs handling

Change controls

Document management

eQMS

GMP/cGMP knowledge

Regulatory knowledge

Communication skills

Analytical skills

Education

Bachelor's degree in Biology, Biotechnology, Biochemistry, Chemistry, Pharmaceutical Sciences, or related field

Tools

eQMS software

Job description

Northway Biotech is seeking an experienced Quality Systems Specialist to support GMP Quality Systems at our Waltham, MA site. This role focuses on maintaining regulatory compliance, managing quality documentation, and supporting deviations, CAPAs, change controls, and continuous improvement in a biologics CDMO environment.

The successful candidate will collaborate across Manufacturing, QC, Validation, and Engineering, oversee electronic quality management systems, and ensure timely completion of