What are the responsibilities and job description for the Quality Assurance Specialist, Batch Records Raw Materials position at Nitto Avecia?
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
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.
- 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.
Salary : $58,300 - $70,700
