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Quality Assurance Compliance Analyst
2 months ago
Position Title: Quality Control Compliance Investigator II
Company: Planet Pharma
Location: Philadelphia, PA
Overview:
The Quality Control (QC) Compliance Investigator II plays a pivotal role in supporting the Laboratory Manager in executing and concluding investigations related to Quality Control. This position demands strong technical writing capabilities, particularly with experience in flow cytometry and ELISA. 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 concerning 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 and maintain a trending database of relevant metrics.
- Revise Quality documents to facilitate 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.
- Basic understanding of biological drug development concerning Quality Control.
- Meticulous attention to detail with robust analytical, written, and verbal communication skills.
- Ability to recognize and respond to time-sensitive situations with a sense of urgency.
- Adaptable and flexible approach 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 writing.
Physical and Mental Demands:
- Ability to sit for extended periods in front of a computer or biological safety cabinet.
- Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to manage work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.
Work Environment:
- This role will operate in both an office and a laboratory environment.
- In the lab, the candidate must be prepared to work with various chemical and biochemical exposures.
- Must be capable of working in a cleanroom with biohazards and human blood components.
- Potential exposure to noise, equipment hazards, and strong odors.
The details provided in this document are intended to outline the general nature and level of work performed by an employee in this role. They are not intended to be an exhaustive list of functions, duties, or local variations. Management retains the discretion to modify the responsibilities of the position at any time.
Compensation: Pay rate will be commensurate with experience, with a target range of $30-50/hr.