Location: Cleveland,OH, USA
Position Overview: The Quality Control Transport/Microbiology Associate assists in all aspects of Transport of Drug Products to treatment centers for the associated drug product. In addition, Transport associate will assist in Microbiology activities in support of GMP testing for Quality Control. Interacts with employees internal and external to Quality Control.
Essential Duties & Responsibilities:
+ Travels to clinical sites by plane and/or car to deliver drug products.
+ Participates in Operating Room observations and product handling/inspection activities.
+ Works on QC tasks of diverse scope, requiring basic knowledge of laboratory concepts.
+ Demonstrates understanding of QC principles and GMPs.
+ Performs Microbiology testing in support of environmental monitoring, in-process samples and finished product analysis.
+ Participates in analyitical troublehooting as needed.
+ Provides input to improving QC systems and procedures to improve GMP.
+ Complies with company documentation practices (GDP).
+ Supports Quality Control for some release testing of clinical and commercial products.
+ Reviews and revises analytical methods, SOPs, test records, and CofAs
+ Supports maintaining laboratory in inspection readiness state.
Performs other duties as assigned by management.
Qualifications:
+ BS in biology, microbiology, molecular biology or other relevant discipline with 1 to 4 years of relevant experience.
+ Experience and knowledge in the pharmaceutical sampling and testing of critical utilities and environmental monitoring within a GMP and/or GLP environments preferred.
+ Experience in traveling to Treatment Sites Strongly preferred.
+ Experience in Cleanroom facilities and/or sterile gowning highly preferred.
+ Experience in Environmental Monitoring highly preferred.
+ Cell Culture Experience highly preferred
+ cGMP or regulated manufacturing or testing experience preferred
+ Experience performing USP (United States Pharmacopeia) compliant testing preferred.
+ Experience with relevant analytical lab equipment and computers preferred.
+ Good mathematical and organizational skills
+ Ability to interact constructively with co-workers to solve problems and complete tasks
+ Travel, weekend work, or late nights may be required as needed.
Physical Demands:
+ A normal range of hearing and vision correctable to 20/20, and Occasional lifting up to 25 pounds is required.
+ Travel up to 50% may be required.
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