Advantage Technical · 1 week ago
Quality Assurance Specialist
Norton, MA
Full-time
Onsite
Mid, Senior Level
2+ years expAdvantage Technical is seeking a Quality Assurance Specialist to support the manufacture of biopharmaceutical products. The role involves ensuring compliance with GMP and regulatory requirements while providing day-to-day Quality Assurance support across various functions at the Norton site.
Staffing & Recruiting
Hiring Manager
Damarys Zambrano, MSIOP
Responsibilities
Provide raw material QA support, including review and approval of incoming material documentation and release for GMP use
Deliver on-the-floor QA support to manufacturing operations, including area clearance and changeover activities
Review and approve SOPs, Master Batch Records (MBRs), specifications, risk assessments, and other quality documents
Author and maintain Quality-related SOPs and controlled forms
Review and approve validation protocols, reports, and executed documentation to ensure compliance with regulatory and procedural requirements
Review and approve QC laboratory qualification and equipment qualification documentation
Perform executed batch record review and approval for accuracy and GMP compliance
Review and approve deviations, CAPAs, change controls, and investigations within the quality management system
Support internal and external audits and regulatory inspections, including document retrieval and subject matter support
Approve maintenance work orders to ensure equipment maintenance and calibration compliance
Collaborate with cross-functional teams to drive continuous improvement and quality excellence at the Norton facility
Qualification
Required
Bachelor's degree in a scientific or engineering discipline (Biology, Chemistry, Biotechnology, Engineering, or related field), or equivalent experience
2–4 years of professional GMP experience in Quality, Manufacturing, or Quality Control (QC)
Strong working knowledge of cGMP regulations (21 CFR Parts 210/211/11, ICH Q7/Q10) and Good Documentation Practices
Experience performing batch record review and supporting manufacturing operations
Excellent attention to detail, organizational skills, and ability to communicate effectively across teams
Preferred
Experience with quality systems such as SAP and Veeva Vault strongly preferred
LIMS experience is a plus; Infor (CMMs) experience is a nice-to-have
Company
Advantage Technical
Advantage Technical aligns people and companies to create opportunity.
10001+ employees
H1B Sponsorship
Advantage Technical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
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Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (1)
2023 (1)
2022 (7)
2021 (10)
2020 (48)
Funding
Current Stage
Late StageCompany data provided by crunchbase