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Quality Control Compliance Investigator II

3 months ago

Philadelphia, United States Planet Pharma Full time

Overview

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. The position will be on-site at the Philadelphia location.

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

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required:

  • Must be able to Sit for an extended amount of time in front of the computer or biological safety cabinet

Mental:

  • Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadline

Work Environment:

  • This position will work in both an office and a manufacturing lab setting.
  • When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
  • Able to work in cleanroom with biohazards, human blood components, and chemicals.
  • Potential exposure to noise and equipment hazards and strong odors.

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.