SpringfieldMARecruiter Since 2001
the smart solution for Springfield jobs

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

Responsibilities:


  • 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

    Qualification:-


    • 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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Springfield RSS job feeds