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Quality Assurance Compliance Analyst

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 plays a crucial role in supporting the Laboratory Manager by facilitating and concluding investigations related to quality control. Candidates should possess strong technical writing capabilities, particularly with experience in flow cytometry and ELISA techniques. Familiarity with CAR-T or TIL environments is advantageous.

Key Responsibilities:

  • Collaborate with the Lab Support Manager and fellow investigators to address audits, deviations, out-of-specification findings, and corrective/preventative actions (CAPA).
  • Engage cross-functionally to assist in investigations concerning deviations and out-of-specification results, focusing on analytical assays such as flow cytometry, ELISA, and microbiological testing.
  • Collect and analyze data to support investigations, maintaining a comprehensive database of relevant metrics.
  • Update quality documentation to aid in the mitigation of deviations 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.
  • Basic understanding of biological drug development in relation to Quality Control.
  • Highly detail-oriented with excellent analytical, written, and verbal communication skills.
  • Ability to recognize time-sensitive situations and demonstrate a sense of urgency.
  • Adaptable and flexible approach with a willingness to embrace challenges.

Preferred Qualifications:

  • Experience with cell and/or gene therapy products.
  • Background in a GMP-regulated laboratory.
  • Familiarity with investigation writing.

Physical and Mental Demands:

  • Ability to sit for extended periods in front of a computer or biological safety cabinet.
  • Strong analytical thinking, judgment, problem-solving, and discretion capabilities.
  • Capacity to manage work-related stress and prioritize multiple tasks effectively.

Work Environment:

  • This role encompasses both office and laboratory settings.
  • In the laboratory, exposure to various chemical and biochemical substances, including latex and bleach, is expected.
  • Work may involve cleanroom environments 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.