Microbiology and Quality Control Transport Specialist

2 weeks ago


Cleveland, Ohio, United States Abeona Full time
Job Overview

The Quality Control Transport/Microbiology Associate plays a vital role in the logistics of Drug Products, ensuring their safe and efficient transport to treatment facilities. This position also encompasses Microbiology responsibilities that support Good Manufacturing Practices (GMP) testing within Quality Control. The associate will collaborate with both internal and external personnel related to Quality Control.


Key Responsibilities:
  • Facilitates the transportation of Drug Products to designated treatment locations.
  • Engages in Quality Control tasks that require a foundational understanding of laboratory practices.
  • Collaborates with the Transport team, which may involve travel to clinical sites for product delivery.
  • Exhibits knowledge of Quality Control principles and GMP regulations.
  • Conducts Microbiology testing to support environmental monitoring, in-process samples, and final product evaluations.
  • Assists in analytical troubleshooting as necessary.
  • Contributes to the enhancement of Quality Control systems and procedures to bolster GMP compliance.
  • Adheres to company documentation standards (Good Documentation Practices).
  • Provides support for Quality Control during the release testing of both clinical and commercial products.
  • Reviews and updates analytical methods, Standard Operating Procedures (SOPs), test records, and Certificates of Analysis (CofAs).
  • Aids in laboratory investigations concerning test failures, discrepancies, and deviations.
  • Ensures the laboratory maintains a state of readiness for inspections.

Additional duties may be assigned by management as required.


Qualifications:
  • Bachelor's degree in biology, microbiology, molecular biology, or a related field, with 1 to 4 years of relevant experience.
  • Preferred experience in pharmaceutical sampling and testing of critical utilities and environmental monitoring within GMP and/or GLP settings.
  • Strongly preferred experience in traveling to treatment sites.
  • Highly preferred background in Environmental Monitoring.
  • Experience with Cell Culture is highly preferred.
  • cGMP or regulated manufacturing/testing experience is preferred.
  • Familiarity with USP (United States Pharmacopeia) compliant testing is preferred.
  • Experience with relevant analytical laboratory equipment and software is preferred.
  • Strong mathematical and organizational skills.
  • Ability to work collaboratively with colleagues to resolve issues and complete tasks.
  • Willingness to travel, work weekends, or late nights as needed.
Physical Requirements:
  • Normal hearing and vision capabilities, correctable to 20/20, with occasional lifting of up to 25 pounds.
  • Travel may be required up to 50% of the time.

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