Quality Assurance Specialist, Batch Records Raw Materials
Quality Assurance Specialist, Batch Records Raw Materials
Posted on :
29-07-2025
Employer Active
1 Vacancy
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Job Description
About this opportunity :
The position is responsible for serving as a lead QA representative for Raw Materials and Batch Records to ensure timely compliant and efficient release in support of manufacturing operations.
Key Responsibilities:
- Responsible for reviewing approving scanning and binding quality records/batch records and raw materials records.
- Review and verify raw material documentation (e.g. Certificates of Analysis Certificates of Compliance and material specifications) for compliance with internal and regulatory requirements.
- Perform QA-related entries and reviews in inventory management systems (e.g. SAP or LIMS) related to raw material status changes (quarantine/release/reject).
- Ensure raw material handling and documentation activities are executed in compliance with applicable SOPs cGMPs and regulatory standards.
- Maintains spreadsheets for the review cycles of quality documents.
- Interact /communicate with various department such as Manufacturing Supply Chain and Quality Control to ensure timely and compliant material release and disposition activities.
- Coordinate corrections for quality documents internally and externally (e.g. client comments)
- Provide assistance to back room during cGMP compliance inspections this includes the retrieving of quality documents/records and any other documentation requested during these inspections.
- Familiarize with Quality Assurance Operations.
- Complete MFG suite walk-throughs (as needed).
- Review HVAC reports (as needed).
- Support periodic audit readiness activities and participate in internal walkthroughs to ensure data integrity and documentation alignment across QA processes.
- Escalate material discrepancies and documentation issues promptly and follow up through closure to ensure timely resolution.
- Collaborate with QA Systems to support trending and KPI reporting related to raw material and batch record review cycle times.
Required Skills/Abilities:
- The job requires a BS/BA in science or equivalent work experience with 1 or more years experience in either Production or Quality Assurance.
- Must be able to gown up and enter Manufacturing suites for walk-throughs and MRB labeling.
The annualized salary range for this role $58300.00 - $70700.00.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
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