Quality Assurance Specialist III Raw Material/Batch Record Review

@ Nitto Denko Corp.
Nitto Denko Corp.nittodenkocorp..com

Quality Assurance Specialist III Raw Material/Batch Record Review

Milford, MA
Posted 1 day ago

About the job

A biotech company seeking a Quality Assurance Specialist III to oversee raw materials and batch records, ensuring compliance and supporting audits with a focus on quality and regulatory standards.

Requirements

  • 5 years' experience in QA or Production
  • BS/BA in science or related field
  • Experience with deviation and MRB processes
  • Strong decision-making skills

Qualifications

  • BS/BA in science or equivalent
  • Gown up for manufacturing suites
  • Experience with deviations/MRB
  • Ability to lead audits

Full job description

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.
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