Quality Assurance Specialist III Raw Material/Batch Record Review

About this opportunity :

As a Quality Assurance Specialist III, you will be responsible for being a lead QA representative for Raw Materials and Batch Records functions.

Key Responsibilities:

• 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).
• 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 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.
• Help track batch records and raw materials.
• Help create and maintain metrics for batch records and raw materials.
• Oversees the QA release meeting to ensure releases on track.
• QA contact with Manufacturing and QC for all batch record issues, corrections, prioritizations, and requests.
• Oversees training of new employees (batch record reviews, raw materials reviews)
• Releases, tracks, prioritizes, and fills requests for raw materials.
• Attend or lead all raw material meetings including interaction with other departments such as QC, Milford Supply Chain, Cincinnati Supply Chain, etc.
• Responsible for ensuring MRBs for raw materials are initiated and completed in a timely manner.
• Supports and reviews QA raw material/batch record CAPAs and Deviations.
• Supports the QA Lead Supervisors.
• Supervise others (as needed).
• Perform walk-through of manufacturing suites (as needed).
• Responsible for 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 as needed.
• Lead internal audits.
• Interface with Manufacturing, Purchasing, QC, Warehouse, and Supply Chain to ensure timely and compliant material release and disposition activities.
• Provide assistance during cGMP compliance inspections of the Milford facility. This includes the retrieving of quality documents/records/trend data and any other documentation requested during these inspections.
• Attend daily QA meetings.
• Review and approved AA and HVAC Reports (as needed).

Required Skills/Abilities:

• The job requires a BS/BA in science or equivalent work experience with 5 years' experience in either Production or Quality Assurance.
• Must be able to gown up and enter Manufacturing suites for walk-throughs and MRB labeling.
• Must have deviation and/or MRB experience.
• Provide sound decision-making and guidance on all aspects of batch record review and raw material release.

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