Onsite QA Specialist - ISO 13485/GMP Compliance & Docs

Boston BioProducts, Inc.; Milford (MA); On-site; USD 65,000 - 85,000; Full time

Job summary

Boston BioProducts, Inc. is looking for a Quality Assurance Specialist based in Milford, MA. The role involves maintaining the Quality Management System, ensuring compliance with quality standards, and supporting product release activities. Candidates must be local and possess a Bachelor’s degree in a scientific discipline along with a minimum of 3-5 years of relevant experience, ideally with knowledge of ISO and GMP standards.

This is a fully onsite position, emphasizing a detailed-oriented approach and strong communication skills. The role serves as a key point of contact for vendors and quality-related inquiries.

Qualifications

• Minimum 3-5 years of relevant experience.
• Strong knowledge of ISO 13485, ISO 9001 and GMP preferred.

Responsibilities

• Ensure products meet customer expectations and quality standards.
• Maintain a Quality Management System compliant with regulations.
• Review quality documentation for accuracy and compliance.
• Support internal and external audits with necessary documentation.

Skills

Attention to detail

Knowledge of ISO 13485

Knowledge of GMP

Written communication skills

Verbal communication skills

Project management

Microsoft Office

Education

Bachelor’s degree in a scientific discipline

Job description

Boston BioProducts, Inc. is looking for a Quality Assurance Specialist based in Milford, MA. The role involves maintaining the Quality Management System, ensuring compliance with quality standards, and supporting product release activities. Candidates must be local and possess a Bachelor’s degree in a scientific discipline along with a minimum of 3-5 years of relevant experience, ideally with knowledge of ISO and GMP standards.

This is a fully onsite position, emphasizing a detailed-oriented approach and strong communication skills. The role serves as a key point of contact for vendors and quality-related inquiries.