Job Description

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:

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• Responsible for reviewing, approving, scanning, and binding quality records/batch records, and raw materials records.
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• Review and verify raw material documentation (e.g., Certificates of Analysis, Certificates of Compliance, and material specifications) for compliance with internal and regulatory requirements.
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• Perform QA-related entries and reviews in inventory management systems (e.g., SAP or LIMS) related to raw material status changes (quarantine/release/reject).
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• Ensure raw material handling and documentation activities are executed in compliance with applicable SOPs, cGMPs, and regulatory standards.
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• Maintains spreadsheets for the review cycles of quality documents.
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• Interact /communicate with various department such as Manufacturing, Supply Chain and Quality Control to ensure timely and compliant material release and disposition activities.
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• Coordinate corrections for quality documents internally and externally (e.g. client comments)
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• 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.
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• Familiarize with Quality Assurance Operations.
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• Complete MFG suite walk-throughs (as needed).
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• Review HVAC reports (as needed).
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• Support periodic audit readiness activities and participate in internal walkthroughs to ensure data integrity and documentation alignment across QA processes.
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• Escalate material discrepancies and documentation issues promptly and follow up through closure to ensure timely resolution.
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• Collaborate with QA Systems to support trending and KPI reporting related to raw material and batch record review cycle times.
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Required Skills/Abilities:

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• The job requires a BS/BA in science or equivalent work experience with 1 or more years' experience in either Production or Quality Assurance.
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• Must be able to gown up and enter Manufacturing suites for walk-throughs and MRB labeling.
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The annualized salary range for this role $58,300.00 - $70,700.00.

Job Tags

Work experience placement,

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