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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