The Quality Control (QC) Compliance Investigator II will assist the Laboratory Manager in advancing and closing QC related investigations. Strong technical writing skills are required with flow cytometry and ELISA experience. Experience in a CAR-T or TIL environment is a plus.
The ideal candidate will have experience working in a GMP-regulated laboratory with knowledge of writing investigations but is not required.
Essential Functions and Responsibilities
- Assists Lab Support Manager and other investigators with responses to audits, deviations, out of specification/lab investigations, and corrective/preventative actions (CAPA).
- Work cross-functionally to support deviations and Out of Specification investigations with an emphasis on analytical assays (flow cytometry, ELISA, and other cell-based assays) and Microbiology assays.
- Gather data in support of deviations and maintain a trending database of applicable metrics.
- Revise Quality documents in support of deviation mitigation and/or CAPAs.
- Other responsibilities as determined.
Required Education, Skills, and Knowledge
- Bachelor’s degree in a relevant discipline (biological sciences or equivalent)
- 1-5 years of experience in the biopharmaceutical industry within a cGMP Quality Control role
- Basic knowledge of biological drug development with respect to Quality Control
- Extremely detail-oriented with strong analytical, written, and verbal communication skills
- Demonstrate sense of urgency; ability to recognize time sensitivity
- Flexible and adaptable style with an eagerness to take on challenges
Preferred Education, Skills, and Knowledge
- Experience with cell and/or gene therapy products
- GMP regulated laboratory experience
- Knowledge of investigation writing
Salary Range-$40-45/hr
