QC Analyst

Job Title: QC Analyst
Location (On-site Remote or Hybrid): Chapel Hill NC (Onsite)
Contract Duration: Contract until 07/16/2027

JOB DESCRIPTION
In her/his function as QC Analytical Development Scientist the person is responsible for the following:

• Sterility and Bioburden Testing
  • Ability to execute Sterility Testing using the BacT Alert Sterility System.
  • Ability to execute Bioburden testing using the BacT Alert System.
  • Develop and execute analytical validations sterility and bioburden.
  • Assist in the development of analytical procedures to support sterility and bioburden testing.
• Release and Stability Testing
  • Familiar with Flow Cytometry PCR and Endotoxin testing.
  • Execute testing procedures for patient products manufactured report results using GDP in a timely fashion and maintain in the batch record.
  • Execute testing on stability programs. Generate results and document findings.
  • Provide guidance to other employees on QC testing and techniques.
  • Responsible for training and mentoring new employees on QC process and analytical methods.
• Analytical Development
  • Review current validations for appropriateness to current standards and requirements.
  • Execute analytical validations as needed i.e. change in analysis to meet FDA requirements establishment of a new site protocol requiring new testing
  • Assist in review of analytical data
  • Perform statistical analysis of results
• Manage the Quality Control requirements for the onboarding of new products
  • Work with manufacturing lead to help bring new products to the facility
  • Coordinate all Quality Control needs method development validation SOP generation material acquisition
• Investigation of existing technology to determine feasibility for new products when needed.
• Develop the sites understanding on testing methods
• Author review and revise forms job aids policies and Standard Operating Procedures
• Participate in 5 hours of continuing education annually in cellular therapy or quality topics
• Responsibilities may be modified or added as needed and discussed with the appropriate management feedback.