Position Overview TheQuality Control Environmental Monitoring Associate assists in all aspects of Microbiology activities in support of GMP testing for Quality Control. Interacts with employees internal and external to Quality Control. In addition, Environmental monitoring associate will assist in Transport of Drug Products to clinical sites and/or treatment centers for the associated drug product. Essential Duties and Responsibilities
Performs Environmental monitoring activities inside and outside of a cleanroom.
Performs Microbiology testing in support of environmental monitoring, in-process samples and finished product analysis.
Works on QC tasks of diverse scope, requiring basic knowledge of laboratory concepts.
Demonstrates understanding of QC principles and GMPs.
Participates in analytical troubleshooting as needed.
Performs validation of various microbiological methods transferred into the QC laboratory.
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
Works with and on the Transport team, including traveling to clinical sites to deliver drug product.
Supports laboratory investigations related to test failures, discrepancies and deviations.
Supports maintaining laboratory in inspection readiness state.
Performs other duties as assigned by management.
Qualifications
BS in biochemistry, biology, microbiology, molecular biology or other relevant discipline with 2 to 4 years of relevant experience.
Experience in Environmental Monitoring highly preferred.
Experience in Glove and Gowning highly preferred.
Experience and knowledge in the pharmaceutical sampling and testing of critical utilities and environmental monitoring within a GMP and/or GLP environments 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.
Ability to interact constructively with co-workers to solve problems and complete tasks
Some travel, weekend work, or late nights may be required as needed.
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