Nitto Avecia · 1 day ago
Quality Assurance Specialist II, Batch Records Raw Materials
Milford, MA
Full-time
Onsite
Entry, Mid Level
$66K/yr - $80K/yr
2+ years expNitto Avecia is a company that focuses on quality assurance in manufacturing processes. They are seeking a Quality Assurance Specialist II to support QA Operations activities, including batch record review and raw materials release, while ensuring compliance with regulatory requirements.
BiotechnologyManufacturingPharmaceutical
Responsibilities
Review and verify raw material documentation (e.g., Certificates of Analysis, Certificates of Compliance, and material specifications) for compliance with internal and regulatory requirements
Responsible for reviewing, approving, scanning, and binding quality records/batch records, and raw materials records
Responsible for knowledge of SAP system for release/rejection of raw materials
Maintains spreadsheets for the review cycles of quality documents
Interact /communicate with various department such as Manufacturing, Supply Chain and Quality Control
Coordinate corrections for quality documents internally and externally (e.g., client comments)
Provide assistance during cGMP compliance inspections of the Milford facility. This includes the retrieving of quality documents/records/trend data and any other documentation requested during these inspections
Attend daily QA meetings
Support Senior/Lead Specialists
Gather/support corrections, quality metric reports to executive management
Provide strong link/communication between the QA function/activities with all other departments at the Milford site
Support Material Review Board (MRB) and labeling of raw materials (as required)
Support Raw material re-evaluation process
Assist in customer documentation requests
Perform walk-through of manufacturing suites (as required)
Help with internal audits of all GMP departments
Assist in deviation and investigation follow-up by coordinating data collection and document retrieval
Contribute to inspection readiness activities, document control harmonization, and trending initiatives in collaboration with QA Systems
Actively participate in continuous improvement efforts related to QA operations, document lifecycle management, and process ownership
Qualification
Required
BS/BA in science or equivalent work experience of at least 2 years' experience in either Production or Quality Assurance
Provide sound decision-making and guidance on all aspects of batch record review and raw material release
Provide strong link/communication between the QA Operations and QA Projects Departments
Interface with Manufacturing, QC, Warehouse, and Supply Chain to ensure timely and compliant material release and disposition activities
Must be able to gown up and enter Manufacturing suites
Company
Nitto Avecia
Oligonucleotides are giving rise to a new generation of therapeutics—and Nitto Avecia is helping lead the way.
501-1000 employees
H1B Sponsorship
Nitto Avecia 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
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (7)
2023 (6)
2022 (10)
2021 (11)
2020 (5)
Funding
Current Stage
Late StageTotal Funding
unknown2011-02-03Acquired
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