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Quality Assurance Compliance Specialist

2 months ago

Philadelphia, Pennsylvania, United States Planet Pharma Full time

Position Title: Quality Control Compliance Investigator II

Company: Planet Pharma

Location: Philadelphia, PA

Overview:

The Quality Control (QC) Compliance Investigator II will play a pivotal role in supporting the Laboratory Manager in the advancement and resolution of quality control-related investigations. Candidates should possess strong technical writing abilities and experience with flow cytometry and ELISA methodologies. Familiarity with CAR-T or TIL environments is advantageous.

Key Responsibilities:

  • Assist the Lab Support Manager and fellow investigators in addressing audits, deviations, out-of-specification investigations, and corrective/preventative actions (CAPA).
  • Collaborate across departments to support investigations related to deviations and out-of-specification results, focusing on analytical assays (flow cytometry, ELISA, and other cell-based assays) as well as microbiological assessments.
  • Collect and analyze data to support deviations while maintaining a trending database of relevant metrics.
  • Revise quality documentation to aid in deviation mitigation and/or CAPAs.
  • Undertake additional responsibilities as assigned.

Required Qualifications:

  • Bachelor's degree in a relevant field (biological sciences or equivalent).
  • 1-5 years of experience in the biopharmaceutical sector within a cGMP Quality Control capacity.
  • Fundamental understanding of biological drug development concerning Quality Control.
  • Meticulous attention to detail with robust analytical, written, and verbal communication skills.
  • Exhibit a sense of urgency and the ability to recognize time-sensitive tasks.
  • Demonstrate flexibility and adaptability, with a willingness to embrace challenges.

Preferred Qualifications:

  • Experience with cell and/or gene therapy products.
  • Experience in a GMP-regulated laboratory setting.
  • Knowledge of investigation documentation.

Physical and Mental Demands:

  • Ability to sit for extended periods while working on a computer or in a biological safety cabinet.
  • Strong analytical thinking, judgment, problem-solving, and discretion capabilities; ability to manage work-related stress and multiple priorities simultaneously.

Work Environment:

  • This role will involve working in both an office and laboratory environment.
  • In the laboratory, candidates must be prepared to work with various chemical and biochemical exposures.
  • Ability to work in a cleanroom setting with biohazards and human blood components.
  • Potential exposure to noise, equipment hazards, and strong odors.

Compensation: Pay rate will be commensurate with experience, with a target range of $30-50/hr.