Microbiology Quality Assurance Specialist

2 weeks ago

Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time
Job Overview

Position Summary:

The Quality Control Analyst will play a crucial role in ensuring the integrity of quality control testing processes at Iovance Biotherapeutics Inc. This position involves comprehensive microbial testing of both in-process and final drug products, focusing on critical assessments such as bioburden, endotoxin levels, gram staining, environmental monitoring, and sterility assurance.

Key Responsibilities:

  • Conduct daily microbiological testing activities in compliance with cGMP standards.
  • Execute scheduled environmental monitoring within cleanroom environments.
  • Analyze data and report results from microbiology assays to facilitate timely product lot releases.
  • Adhere strictly to cGMP regulations during all laboratory activities.
  • Assist in thorough investigations for any out-of-specification results.
  • Perform trending analysis on environmental monitoring data.
  • Engage in technical problem-solving initiatives.
  • Support product stability programs through the execution of stability tests, data analysis, and comprehensive reporting.
  • Maintain a high level of efficiency and accuracy in all tasks.

Qualifications:

  • Bachelor's degree in a relevant scientific discipline (biological sciences or equivalent).
  • A minimum of one year of experience in a Quality Control role within the pharmaceutical sector; experience with cell therapy products is advantageous.
  • Ability to collaborate effectively with cross-functional teams.
  • Strong attention to detail and technical proficiency.
  • Capable of managing multiple priorities under tight deadlines while maintaining productivity.
  • Demonstrated ownership and accountability in work responsibilities.
  • Exhibit a sense of urgency and awareness of time-sensitive tasks.

Physical and Mental Requirements:

  • Must be able to wear appropriate cleanroom attire and Personal Protective Equipment (PPE).
  • Ability to meet requirements for wearing a half-face respirator.
  • Capable of standing or walking for the majority of a 10-hour workday, including climbing as necessary.
  • Must possess near vision acuity for close-range sample analysis.
  • Ability to perform physical tasks involving bending, twisting, reaching, and repetitive motions.
  • Must be able to lift and carry objects weighing up to 45 pounds.

Work Environment:

  • This role involves working in both office and laboratory settings.
  • Laboratory work may involve exposure to various chemicals and biological materials.
  • Must be prepared to work in cleanroom conditions with potential biohazards.
  • Exposure to noise and equipment hazards may occur.

Iovance Biotherapeutics Inc is dedicated to fostering a diverse and inclusive workplace. We are an equal opportunity employer, and all qualified applicants will be considered without regard to race, color, religion, sex, national origin, age, disability, marital status, sexual orientation, gender identity, or any other characteristic protected by law.

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