Quality Assurance Specialist III Raw Material/Batch Record Review

About the Role

As a lead QA representative, you will oversee Raw Materials and Batch Records functions, ensuring compliance with internal and regulatory requirements.

Responsibilities

• Review and verify raw material documentation (e.g., Certificates of Analysis, Certificates of Compliance, and material specifications) for compliance.
• Perform QA-related entries and reviews in inventory management systems (e.g., SAP or LIMS) for raw material status changes (quarantine/release/reject).
• Assist in the documentation and investigation of raw material-related deviations, discrepancies, and OOS/OOT results in coordination with QA and QC teams.
• Assist with Deviations and CAPAs for the Batch Record/Raw Material group.
• Open and complete MRB DEVNs for the raw material department.
• Participate in the evaluation of changes related to raw materials (e.g., supplier, specification, or process changes) under the QA change control process.
• Track batch records and raw materials, and create/maintain related metrics.
• Oversee the QA release meeting to ensure releases stay on track.
• Serve as QA contact with Manufacturing and QC for all batch record issues, corrections, prioritizations, and requests.
• Oversee training of new employees on batch record reviews and raw materials reviews.
• Release, track, prioritize, and fill requests for raw materials.
• Attend or lead raw material meetings, interfacing with departments such as QC, Milford Supply Chain, and Cincinnati Supply Chain.
• Ensure MRBs for raw materials are initiated and completed in a timely manner.
• Support and review QA raw material/batch record CAPAs and Deviations.
• Support QA Lead Supervisors and supervise others as needed.
• Perform walk-throughs of manufacturing suites as needed.
• Maintain knowledge of SAP system for release/rejection of raw materials.
• Prepare raw material-related documents and files for internal, customer, or regulatory audits.
• Participate in audit backroom activities and lead internal audits.
• Interface with Manufacturing, Purchasing, QC, Warehouse, and Supply Chain to ensure timely and compliant material release and disposition.
• Provide assistance during cGMP compliance inspections, including retrieving quality documents/records/trend data.
• Attend daily QA meetings.
• Review and approve AA and HVAC Reports as needed.

Requirements

• BS/BA in science or equivalent work experience with 5 years’ experience in Production or Quality Assurance.
• Ability to gown up and enter Manufacturing suites for walk-throughs and MRB labeling.
• Deviation and/or MRB experience.
• Strong decision-making and guidance skills for batch record review and raw material release.

Pay

The annualized salary range for this role is $73,700.00 - $89,177.00.