Quality Assurance Specialist

Boston BioProducts is seeking a Quality Assurance Specialist to support and maintain our Quality Management System (QMS) and ensure compliance with applicable quality standards and regulatory requirements. This is a 100% onsite (Mon‑Fri) position based in Milford, MA. Direct applicants only – no staffing agencies or third‑party recruiters.

Responsibilities

• Ensure products manufactured by BBP meet or exceed customer expectations and quality standards.
• Work in conjunction with the Quality team and management to maintain a Quality Management System that complies with current regulatory and industry requirements.
• Review batch records and other relevant documents to ensure accuracy, completeness, and compliance with Good Documentation Practices (GDP) and established procedures.
• Create the Certificate of Analysis (CoA) and ensure all product specifications are accurate.
• Identify and report any discrepancies observed during batch record reviews to the Quality Operations Manager.
• Ensure that the product meets specification and client criteria prior to release.
• Oversee the releasing and rejecting of materials, intermediates, packaging, and labeling materials, as applicable.
• Review in‑process forms, protocols, and records for adherence to GDP.
• Ensure that CoA, Safety Data Sheet (SDS), and BSE/TSE statements are obtained from vendors.
• Communicate with vendors as needed to obtain necessary documentation for incoming materials.
• Coordinate with the commercial team to initiate Change Orders and Deviations related to products per customer request.
• Coordinate with other departments to ensure releasing raw materials and finished goods within the timeline.
• Assist the Quality Engineer with drafting, processing, investigation, and reporting of Deviations, NCRs, CAPAs, and customer complaints.
• Assist in investigating and identifying root causes using appropriate analytical techniques for NCR investigations.
• Perform QA periodic checks of all functional areas.
• Ensure that CoA, BSE/TSE statements, and other documents generated within BBP are correct and delivered in a timely manner.
• Maintain Quality Records and production documentation within the electronic QMS (eQMS).
• Draft, review, and update QMS documentation as needed.
• Support internal and external audits by preparing documentation, participating in audit activities, and assisting with follow‑up actions.
• Assist the Quality Operations Manager in responding to customer inquiries related to quality systems, compliance, and product documentation.

Education

Bachelor’s degree in a scientific discipline or equivalent.

Experience

Minimum 3–5 years of relevant experience.

Knowledge & Skills

• Ability to follow instructions precisely, recognize deviations, and recommend corrective action within the scope of training.
• Preferably strong knowledge of ISO 13485, ISO 9001, and GMP.
• Strong written and verbal communication skills, a detail‑oriented work ethic, and the ability to understand recognized regulations such as ISO and GMP.
• Ability to work independently, adhering to quality, production, and customer expectations and timelines.
• Computer literate and experienced with Microsoft Office.
• Demonstrated skills in developing and organizing systems for the management of information.
• Preferably strong knowledge of chemistry.
• Ability to meet deadlines, multitask, and change priorities while maintaining productivity.
• Well‑developed attention to detail and the ability to maintain accurate records.