Microbiology Quality Control Specialist

1 week ago


Florham Park, New Jersey, United States Celularity Full time
Job Overview

Celularity Inc. is a pioneering biotechnology firm focused on advancing cellular medicine through innovative placental-derived allogeneic cell therapies aimed at treating various diseases, including cancer and immune disorders. Our mission is to leverage the unique properties of placental cells to create effective, accessible, and affordable therapeutic solutions.

Position Summary

The Microbiology Specialist plays a crucial role in ensuring the quality and safety of our clinical and commercial products. This position encompasses responsibilities such as environmental monitoring, managing deviations in testing, and ensuring laboratory readiness for microbiological assessments.

Key Responsibilities
  • Conduct routine laboratory testing and environmental monitoring in compliance with GTP and GMP standards.
  • Collaborate with cross-functional teams to ensure operational efficiency and timely completion of testing.
  • Execute aseptic gowning procedures and maintain compliance with cleanroom protocols.
  • Adhere to Good Documentation Practices while entering data into electronic systems.
  • Implement SOPs and provide technical updates to management as necessary.
  • Maintain a high level of attention to detail while performing repetitive tasks accurately.
  • Utilize various microbiological techniques and assist in technical writing and data analysis.
  • Communicate effectively with team members and management to meet project timelines.
  • Participate in investigations and corrective actions, contributing to continuous improvement initiatives.
  • Prepare documentation for deviations, out-of-specification results, and change controls.
  • Contribute to departmental goals and serve as a Subject Matter Expert when required.
Qualifications
  • Bachelor's degree in Biology or a related scientific field, with a focus on microbiology preferred.
  • Strong organizational skills and the ability to manage time effectively.
  • Excellent verbal and written communication skills with a keen attention to detail.
  • Physical capability to perform tasks in cleanroom environments, including lifting and gowning.
  • Flexibility in scheduling, with the potential for weekend and off-hour work.
  • Experience in writing deviations and conducting investigations is a plus.
Preferred Experience
  • At least 2 years of relevant experience in Environmental Monitoring within cGMP settings.
  • Familiarity with federal regulations regarding Quality Systems and GMP manufacturing.
  • Demonstrated technical proficiency and scientific creativity.
  • Knowledge of GxP regulations and independent work capabilities.
Working Environment
  • This position primarily operates in cleanroom environments, requiring daily gowning and adherence to safety protocols.
  • Fast-paced work setting that may require extended hours to support manufacturing activities.
  • Ability to lift and transport materials weighing up to 25 pounds regularly.

This job description outlines the essential functions and responsibilities of the role. Additional duties may be assigned as necessary to meet organizational needs.



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