Microbiology Quality Assurance Specialist

2 weeks ago


Cleveland, Ohio, United States Abeona Full time
Position Overview

The Quality Control Transport/Microbiology Associate plays a crucial role in the transportation of pharmaceutical products to various treatment facilities. This position also involves supporting microbiological activities that are essential for Good Manufacturing Practice (GMP) testing within the Quality Control department. The associate will collaborate with both internal and external stakeholders in Quality Control.

Key Responsibilities
  • Facilitates the delivery of pharmaceutical 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 include travel to clinical sites for product delivery.
  • Exhibits a solid grasp of Quality Control principles and GMP regulations.
  • Conducts microbiological testing to support environmental monitoring, in-process evaluations, and final product assessments.
  • Assists in analytical troubleshooting as necessary.
  • Contributes to the enhancement of Quality Control systems and procedures to ensure compliance with GMP standards.
  • Adheres to company documentation protocols (Good Documentation Practices).
  • Provides support for Quality Control in 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 is maintained in a state of readiness for inspections.
Qualifications
  • Bachelor's degree in biology, microbiology, molecular biology, or a related field, along 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 experience in environmental monitoring.
  • Cell culture experience is highly preferred.
  • Experience in cGMP or regulated manufacturing/testing environments is preferred.
  • Familiarity with USP (United States Pharmacopeia) compliant testing is preferred.
  • Experience with relevant analytical laboratory equipment and computer systems 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 required.
Physical Requirements
  • Normal hearing and vision, correctable to 20/20, with occasional lifting of up to 25 pounds.
  • Willingness to travel up to 50% as needed.

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