Quality Systems Specialist

Position Summary

Northway Biotech is seeking an experienced Quality Systems Specialist to support GMP Quality Systems at our Waltham, MA site. This position is responsible for maintaining compliance with regulatory requirements, managing quality documentation, and supporting deviations, CAPAs, change controls, and continuous improvement initiatives within a biologics CDMO environment.

Position responsibilities: Ensure compliance of Quality Systems and documentation with cGMP regulations and internal procedures. Generate, review, revise, and maintain controlled GMP documentation, including SOPs, policies, forms, and work instructions. Support the management of deviations, CAPAs, change controls, and related quality investigations.

Review GMP documentation, including specifications, analytical methods, validation protocols, and technology transfer documents. Coordinate document control activities, including issuance, version control, periodic reviews, and archival. Monitor Quality System activities, maintain tracking reports, and ensure timely completion of assigned actions.

Support internal audits, customer audits, and regulatory inspections, including documentation preparation and follow-up activities. Collect and compile information for periodic product quality reviews, quality metrics, and management reports. Maintain and support electronic Quality Management Systems (eQMS) and GMP training documentation.

Collaborate with Manufacturing, QC, Validation, Engineering, and other departments to ensure compliance and support continuous improvement. Position requirements:

• Bachelor's degree in Biology, Biotechnology, Biochemistry, Chemistry, Pharmaceutical Sciences, or a related field.
• Minimum 3 years of experience in Quality Assurance; Quality Systems or similar field within a GMP-regulated pharmaceutical or biotechnology environment.
• Strong understanding of cGMP regulations, FDA requirements, and GMP documentation practices.
• Hands-on experience with deviations, CAPAs, change controls, and document management.
• Experience working with electronic Quality Management Systems (eQMS).
• Previous experience in biologics manufacturing or a CDMO environment preferred.
• Strong organizational, analytical, problem-solving, and communication skills.
• Ability to independently manage multiple priorities and meet deadlines in a fast-paced environment.
• Proficiency in Microsoft Office and excellent written and verbal English communication skills.