QA Investigator

3 weeks ago


Lenoir, United States Stallergenes Greer Full time
Job DescriptionJob Description

Stallergenes Greer is a fully integrated global biopharmaceutical company specialising in the diagnosis and treatment of allergies through the development and commercialisation of allergen immunotherapy (AIT) products and services.

Our purpose is to enable precision medicine to improve life for people with allergies.

Stallergenes Greer has an extensive global footprint, the largest allergen and finished AIT product manufacturing capacity globally. The company’s broad product portfolio, available in multiple formulations (subcutaneous, sublingual drops and tablets), offers patients innovative solutions to improve life for people with allergies.

This position will require the employee to fulfill the following general requirements for employment at Stallergenes Greer and includes but is not limited to:

QA Investigator Job Task(s):

  • Technical writing skills
  • Critical thinking skills and detail oriented
  • Creation of general business documents and procedures
  • Ability to understand applicable governmental regulations
  • Participates in internal and external audits, travel may apply
  • Communicates issues to Quality Management
  • Ability to collaborate as a member of cross-functional teams
  • Support regulatory inspections
  • Support media fills

Performs/reviews the following as applicable by functional unit:

    • Deviations
    • Complaints
    • Discrepant Material reports
    • Laboratory Out of Limits
    • Building Monitoring System Out of Limits
    • Calibration Out of Tolerance
    • Product Out of Yield
    • Corrective/Preventative Action reports
    • Critical System Work Orders
    • Change Notifications
    • Change Requests
    • Document revisions
    • Protocols
    • Compilation of metrics
  • Additional tasks as required

 

QA Investigator Education Requirements:

Associates or Bachelors in Science field


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