Quality Assurance Specialist III Raw Material/Batch Record Review

this opportunity•Milford, MA

1d•Onsite

About The Position

As a Quality Assurance Specialist III, you will be responsible for being a lead QA representative for Raw Materials and Batch Records functions. This role involves reviewing and verifying raw material documentation, performing QA-related entries in inventory systems, assisting with investigations of deviations and discrepancies, and participating in change control processes. You will also be responsible for tracking batch records and raw materials, creating metrics, overseeing the QA release meeting, and serving as the QA contact for batch record issues. Additionally, you will oversee training, manage raw material releases, attend relevant meetings, and ensure timely completion of MRBs. This position supports QA Lead Supervisors and may involve supervising others, performing manufacturing suite walk-throughs, and utilizing SAP for raw material release/rejection. You will also prepare audit documentation, participate in audits, and interface with various departments to ensure compliant material release activities. Assistance during cGMP compliance inspections, including document retrieval, is also a key part of this role. You will attend daily QA meetings and review/approve AA and HVAC Reports as needed.

Requirements

BS/BA in science or equivalent work experience
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.

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).