View Our Website View All Jobs

QC Specialist (Second Shift)

SUMMARY

The Quality Control Specialist will be responsible for conducting in-process and finished product testing associated with Adaptimmune clinical trial material. In addition, the role will be working with other departments for deviations and method transfers.

 

RESPONSIBILITIES

60%

In-process, finished product and stability testing of clinical trial material

20%

Maintenance of Quality Control Protocols, SOP’s and Test Methods

15%

Deviations, change controls, CAPAs

5%:

Method / Technology Transfer of existing methods into the Adaptimmune QC Lab

 

REQUIREMENTS

  • 3+ years working in a GMP quality control laboratory
  • Proficient knowledge of GMP regulations including USP and EP testing requirements
  • Experience conducting time critical testing of in-process and finished product to meet clinical trial needs.
  • Ability to prepare data trending reports, and to author, review and maintain test methods, qualification protocols, SOPs and reports
  • Conduct laboratory investigations and of prepare deviations and CAPAs as needed
  • Ability to identify and implement continuous improvement projects for lab process efficiencies
  • Ability and desire to effectively work in an interdisciplinary team environment and to effectively interact at multiple levels within the company to support internal manufacturing capabilities
  • Ability to work independently on complex tasks
  • Ability to work on assigned projects independently with limited supervision.
  • Familiarity with flow cytometry, ELISA, endotoxin testing, cell-based potency assays and sterility testing
  • Knowledge of GMP regulations including USP and EP testing
  • Method / Technology transfer experience
  • Technical writing skills for drafting equipment and laboratory standard operating procedures
  • Experience in coordinating testing activity and data management
  • Core foundational knowledge and intermediate experience with flow cytometry, ELISA, Endotoxin testing, cell-based potency assays and sterility methods

 

Read More

Apply for this position

Required*
Apply with
Attach resume as .pdf, .doc, .docx, .odt, .txt, or .rtf (limit 5MB) or Paste resume

Paste your resume here or Attach resume file