Quality Assurance Specialist

BioSpace; Milford (MA); On-site; USD 65,000 - 90,000; Full time

Job summary

Boston BioProducts is seeking a Quality Assurance Specialist to support and maintain the Quality Management System (QMS) and ensure compliance with applicable quality standards and regulatory requirements. The QA Specialist reviews quality documentation, supports product release activities, and serves 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 in a regulated environment.
• Experience with ISO 13485, ISO 9001 and GMP is preferred.
• Proficient in documentation and change control processes.
• Strong attention to detail and ability to meet deadlines.

Responsibilities

• Review quality documentation and ensure products meet quality standards.
• Support product release activities and deviations/NCRs/CAPAs.
• Coordinate with vendors to obtain CoA, SDS, and regulatory docs.
• Maintain QMS documentation and participate in audits.
• Assist in investigations and root-cause analysis for NCRs.
• Ensure timely release of materials and documentation.

Skills

Follow instructions

ISO 13485

ISO 9001 / GMP

Communication skills

Independent work

MS Office

Documentation management

Chemistry knowledge

Attention to detail

Education

Bachelor’s degree in a scientific discipline

Tools

eQMS

Job description

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

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.