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Sr. Quality Assurance Specialist (Gene Therapy Industry)

Company: Harba Solutions Inc.
Location: Cambridge
Posted on: January 13, 2022

Job Description:

Department Description:
The Quality Assurance department ensures that the site operates at a high level of compliance and ensures quality decisions are being made in accordance with site requirements.
Core Responsibilities:

  • Responsible for record documentation and for final batch disposition for gene therapy products
  • Support day to day operations, including batch record and label issuance, archiving and verification
  • Review and approve product and process deviations.
  • Follow written procedures for review and release of the intermediate and final product.
  • Follow Standard Operating Procedures (SOP) as needed.
  • Participate in audits to ensure compliance to cGMPs and Company requirements.
  • Identifies deficiencies and works with internal departments to remedy them.
    Basic Qualifications
    • Bachelors Degree in a related field or Biotechnology Certification
    • GMP experience

Keywords: Harba Solutions Inc., Cambridge , Sr. Quality Assurance Specialist (Gene Therapy Industry), Healthcare , Cambridge, Massachusetts

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