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QA Specialist

Company: Integrated Resources, Inc
Location: Agawam
Posted on: January 26, 2023

Job Description:

The QA Specialist I supports the Quality Management System (QMS) and the Document Management System (DMS) in a GMP regulated environment according to established operating procedures. The QMS and DMS functional areas include but are not limited to: Document Control, Training, Deviations, Out of Specification Investigations, Corrective and Preventive Actions (CAPA), Change Control, Complaints, Quality review of analytical and microbiological data and batch production records, Internal Audits, Supplier/Subcontractor Management, Validation, and Calibration & Maintenance


  • Provides quality evaluation and release of support materials, products, equipment and facilities
  • Maintains quality databases and may perform analysis and trending
  • Assists with quality improvement initiatives as needed
  • Supports the DMS including revising and effective dating documents, assisting with training curriculums and providing end user support.
  • Performs internal audits
  • Maintains working knowledge of regulations
  • Analyzes information for accuracy and compliance to internal procedure, cGMP and other regulatory guidelines.
  • Controlled document and record review, e.g. SOP, validations, analytical test records
  • Review of master batch records and executed batch records
  • Effectively performs a variety of duties on schedule, with accuracy and competency
  • Maintains accurate files and records
  • Complies with company policies and SOPs; performs assigned tasks carefully and on schedule according to SOPs.
  • Performs other duties as assigned


    • Related BA/BS degree with 0-2+ years experience or equivalent.
    • Good understanding of GMP / GLP policies and regulations
    • Knowledge of basic concepts, practices and procedures
    • General knowledge of chemistry and scientific calculations
    • Must have understanding of Quality Management Systems
    • Good skills with MasterControl and/or DMS applications
    • Technical experience and knowledge in developing documentation workflows
    • Working knowledge and understanding of software validation principles
    • Good knowledge of regulations and SOPs applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise.

Keywords: Integrated Resources, Inc, Springfield , QA Specialist, Other , Agawam, Massachusetts

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