Onsite Quality Assurance & QMS Specialist

BioSpace; Milford (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

Boston BioProducts in Milford, MA is seeking a Quality Assurance Specialist to support and maintain our Quality Management System (QMS) and ensure regulatory compliance. The QA Specialist will review quality documentation, support product releases, and serve as a primary contact for vendor and customer quality inquiries.

Responsibilities include creating CoA, verifying product specifications, maintaining GDP-compliant records, coordinating with suppliers and internal teams, and assisting with

Qualifications

• Bachelor’s degree in a scientific discipline or equivalent.
• Minimum 3–5 years of relevant QA experience.
• Experience with ISO 13485, ISO 9001 and GMP.
• Strong writing and verbal communication, attention to detail.
• Ability to work independently and meet deadlines.
• Experience with eQMS and quality records.

Responsibilities

• Ensure products meet customer expectations and quality standards.
• Maintain a QMS that complies with regulatory requirements.
• Review batch records for accuracy and compliance with GDP.
• Create CoA and ensure product specifications are accurate.
• Identify discrepancies during batch reviews and report them.
• Coordinate with vendors for CoA, SDS, and documentation.
• Support deviations, NCRs, CAPAs and customer complaints.
• Assist in root-cause investigations using appropriate techniques.
• Maintain quality records and production documentation in the eQMS.
• Support internal and external audits and follow-up actions.

Skills

ISO 13485

GMP knowledge

Quality systems

Documentation

Microsoft Office

Attention to detail

Communication skills

Education

Bachelor’s degree in a scientific discipline

Tools

eQMS

Microsoft Office

Job description

Boston BioProducts in Milford, MA is seeking a Quality Assurance Specialist to support and maintain our Quality Management System (QMS) and ensure regulatory compliance. The QA Specialist will review quality documentation, support product releases, and serve as a primary contact for vendor and customer quality inquiries.

Responsibilities include creating CoA, verifying product specifications, maintaining GDP-compliant records, coordinating with suppliers and internal teams, and assisting with