Quality Assurance Specialist

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 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.