Quality Assurance Specialist II, Batch Records Raw Materials

About this opportunity :

In this position you will support day-to-day QA Operations activities such as batch record review, release of raw materials, review of AA and HVAC reports, customer corrections and following cGMP practices and guidelines. This role serves as a key quality interface between operational teams and quality oversight functions.

Key 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.

Required Skills/Abilities:

• The job requires a 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.

The annualized salary for this position is $65,600.00 - $79,800.00.