Onsite QA Specialist: Quality Systems & Compliance

BioSpace; Milford (MA); On-site; USD 70,000 - 95,000; Full time

Job summary

Boston BioProducts is seeking a Quality Assurance Specialist to support and maintain our Quality Management System (QMS) and ensure compliance with quality standards and regulatory requirements. The QA Specialist is responsible for reviewing quality documentation, supporting product release activities, and serving as a key contact for vendors and customer quality-related requests.

This is a 100% onsite position based in Milford, MA.

Qualifications

• Bachelor’s degree in a scientific discipline or equivalent.
• 3-5 years of relevant QA experience.
• Strong knowledge of ISO 13485, ISO 9001 and GMP.
• Experience with documentation and batch records.
• Ability to work with vendors and cross-functional teams.

Responsibilities

• Ensure products meet quality standards
• Maintain QMS and regulatory compliance
• Review batch records and CoA
• Coordinate with vendors for required documents
• Assist deviations, NCRs, CAPAs and customer complaints
• Support internal and external audits
• Draft and update QMS documentation
• Respond to customer inquiries related to quality

Skills

Quality systems

GDP knowledge

ISO 13485

ISO 9001

GMP

Documentation

Attention to detail

Communication skills

Microsoft Office

Education

Bachelor’s degree in a scientific discipline

Tools

eQMS

Microsoft Office

Job description

Boston BioProducts is seeking a Quality Assurance Specialist to support and maintain our Quality Management System (QMS) and ensure compliance with quality standards and regulatory requirements. The QA Specialist is responsible for reviewing quality documentation, supporting product release activities, and serving as a key contact for vendors and customer quality-related requests.

This is a 100% onsite position based in Milford, MA.