Quality Assurance Specialist

BioSpace; Milford (MA); Sur place; USD 70 000 - 90 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

ISO 13485

GMP knowledge

Quality systems

Documentation

Microsoft Office

Attention to detail

Communication skills

Formation

Bachelor’s degree in a scientific discipline

Outils

eQMS

Microsoft Office

Description du poste

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. The QA Specialist is responsible for reviewing quality documentation, supporting product release activities, enssuring final products meet established quality standards, and serving as a key point of contact for vendors and customer quality-related requests. This is a 100% onsite (Mon-Fri) position based in Milford, MA- LOCAL CANDIDATES ONLY

• Direct Applicants ONLY - No Staffing Agencies or Third-Party Recruiters.

Responsibilities

• Ensure products manufactured by BBP meets or exceeds customer expectations and quality standards


• Works 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 GDP and established procedures.


• Create the 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 the specification and client criteria prior to release.


• Ensure the releasing and rejecting of materials, intermediates, packaging, and labeling materials, as applicable.


• Review In process forms, protocols, and records for adherence to Good Documentation Practices (GDP).


• Ensure that Certificate of Analysis (CoA), Safety Data Sheet (SDS), and BSE/TSE statements are obtained from vendors. Communicate with vendors as needed to obtain the 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 the root cause using appropriate analytical techniques for NCR investigations.


• Perform QA periodic checks of all the functional area


• 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 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

Requires a 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 9001and GMP


• Have 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


• Demonstrate the ability to meet deadlines, multitask, and change priorities while maintaining productivity.


• Possesses well-developed attention to detail and the ability to maintain accurate records.