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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 crucial role in supporting the Laboratory Manager by facilitating and concluding investigations related to quality control. Candidates should possess strong technical writing abilities, with a background in flow cytometry and ELISA being advantageous. Experience in CAR-T or TIL environments is also beneficial.
Key Responsibilities:
- Collaborate with the Lab Support Manager and fellow investigators to address audits, deviations, out-of-specification investigations, and corrective/preventative actions (CAPA).
- Engage cross-functionally to assist with deviations and out-of-specification investigations, focusing on analytical assays such as flow cytometry, ELISA, and microbiological assessments.
- Collect and analyze data in support of 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.
- Highly detail-oriented with exceptional analytical, written, and verbal communication skills.
- Ability to recognize time-sensitive tasks 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.
- Prior experience in a GMP-regulated laboratory.
- Familiarity with investigation writing.
Physical and Mental Demands:
- Must be capable of sitting for extended periods while working at a computer or biological safety cabinet.
- Ability to think clearly and conceptually, demonstrating excellent judgment, problem-solving skills, and discretion.
- Capacity to manage work-related stress and handle multiple priorities simultaneously.
Work Environment:
- This role involves working in both an office and a laboratory setting.
- In the lab, the individual must be prepared to work with various chemical and biochemical exposures.
- Potential exposure to biohazards, human blood components, and chemicals.
- May encounter noise, equipment hazards, and strong odors.
Compensation: Pay rate will be commensurate with experience, with a target range of $30-50/hr.
