Quality Control Specialist II, Sterility Assurance

6 hours ago


Philadelphia, Pennsylvania, United States Planet Pharma Full time
Job Title: Quality Control Specialist II, Sterility Assurance

We are seeking a highly skilled Quality Control Specialist II, Sterility Assurance to join our team at Planet Pharma. This role will be responsible for ensuring the harmonized execution of contamination control policies across our manufacturing sites.

Key Responsibilities:
  • Collaborate with stakeholders to develop and implement sterility assurance principles and contamination control strategies.
  • Support site compliance with global microbial control standards and procedures.
  • Design and implement contamination control strategies and risk assessments.
  • Develop and maintain microbial contamination and cross-contamination risk assessments.
  • Perform environmental monitoring and utility trending reports.
  • Support the development of new product introductions and process designs.
  • Qualify laboratory equipment for microbiological testing.
  • Align and harmonize global microbiological and aseptic standards, policies, and procedures.
  • Participate in facility design and modification, cleaning, and sanitization programs.
  • Participate in inspections and troubleshoot contamination-related issues.
Requirements:
  • Bachelor's degree in a relevant discipline (biological sciences or equivalent).
  • Minimum three (3) years of experience in the pharmaceutical industry within a Quality Control microbiology role.
  • Knowledge and familiarity with cGMP/ICH/FDA/EU Annex 1 compliance regulations and USP, EP, and JP monographs for microbiology.
  • Knowledge of microbiological and sterility testing, media fills, environmental monitoring, microbiology methods (endotoxin, mycoplasma, and sterility).
  • Experience with microbiological risk assessments.
  • Excellent analytical, written, and verbal communication skills.
  • Ability to manage multiple priorities and work in a fast-paced environment.
Preferred Qualifications:
  • Advanced degree preferred.
  • Experience with cell therapy products is a plus.

We offer a competitive salary and benefits package. If you are a motivated and detail-oriented individual with a passion for quality control, we encourage you to apply.



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