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:

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• 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