Quality Assurance Specialist, Batch Records Raw Materials

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 $58,300.00 - $70,700.00.