Quality Assurance Specialist, Batch Records Raw Materials

Overview

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 departments 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, including retrieving 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 is $58,

• $70,

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