QC Specialist II, Cell Therapy (Second Shift)

QC Specialist II, Cell Therapy (Second Shift)
Waltham, MA

Our client is a cell and gene therapy technology company built to power the development of transformative cell and gene therapies today and for many decades to come.

This position is on our QC Cell Therapy team. This is a second shift position and the schedule will consist of 4, 10 hour days. The working hours will be 2:00pm-12:00am (midnight). The working days will be either Sunday through Wednesday or Wednesday through Saturday. The schedule may also be inclusive of working holidays. 

The Role:

The QC Specialist II will support product release testing within the QC analytical laboratory at their facility in Waltham. In this role, you will be responsible for qualifying, writing/reviewing protocols for, and executing cell and molecular biology assays for gene and cell therapy programs. Additionally, the QC Specialist II will investigate and review excursions and deviations generated during qualification and testing. 

Here’s What You’ll Do:

  • Work cross-functionally with QC Analytical Development to qualify and transfer developed assays.
  • Draft and review qualification/validation methods as well as associated test methods/SOPs and reports.
  • Perform routine analytical tests, analyze results, and record data/report in LIMS.
  • Collaborate with other QC functions to ensure all testing is completed within established timelines.
  • Investigate and review analytical testing excursions, including deviations, CAPAs and OOSs.
  • Assist in the training of laboratory staff.

Requirements:

  • Bachelor’s, or Master’s, degree in a technical discipline (Biology/Chemistry/Microbiology or related field) with a minimum of 4 years of experience, or 2 years with Master’s degree. Experience in a GMP QC laboratory setting is preferred.
  • Significant experience with cell and gene therapy test methodologies (PCR, Flow Cytometry, ELISA,  and cell-based assays). Significant experience with flow cytometry and/or PCR methods are preferred.
  • Experience drafting test methods and associated qualifications/validations.
  • Experience performing laboratory investigations.
  • Ability to work independently and communicate/collaborate with scientific/technical personnel.
  • Excellent organizational skills and attention to detail.
  • Significant knowledge of GMPs, SOPs, and Quality System processes.  
  • Experience in cell and gene therapy manufacturing environment is a plus.
  • Experience working with electronic systems (LIMS, CMMS, QMS, ERP) is a plus.