QC Microbiologist - Contract position - Rockville, Maryland MD

Proclinical is seeking a dedicated and innovative Expert Science in Quality Control Microbiology. This role is on a temporary contract and is based in Rockville.

Primary Responsibilities:

The successful candidate will have the opportunity to implement novel technology into biological and pharmaceutical products and processes, with a particular focus on endotoxin detection methods.

Skills & Requirements:

BSc in Biological Sciences or related area; Microbiology, Biochemistry or a related subject.Experience in research and/or analytical development and/or quality control functions.Demonstrated experience and good working knowledge of method development, method validation/qualification.Experience with GMP laboratory operations.Strong team working skills and ability to perform collaborative work across interdisciplinary groups.Strong desire to learn and scientific curiosity.Good organizational skills, ability to multitask and adapt to fast changing priorities and deadlines.Excellent verbal and written communication skills in English.Self-motivation.Understanding of the theoretical and practical aspects of Pharmaceutical Microbiology.Experience in endotoxin detection methods of pharmaceutical products and/or water.Capacity to think innovatively and flexibly for new microbiology methodology implementation.Experience in microbiology method and equipment development and/or validation.Knowledge of biological and pharmaceutical product manufacturing and microbial control.Experience with FDA regulations.The Quality Control Microbiologist's responsibilities will be:Drive the implementation of new and rapid microbiology technologies that meet our quality standards and support regulatory submissions.Design and execute method development and GMP validation for recombinant factor C endotoxin testing.Contribute to method development and qualification.Perform laboratory operations to support the implementation of compliant, state-of-the-art methodology and instrumentation.Provide scientific understanding and analytical support for the development of new test methods, validation, and specifications.Support scientific report writing and document revision.Provide analytical troubleshooting support for investigations requiring non-routine/specialized service.Support microbiology technology validation and implementation for testing pharmaceutical products and the manufacturing environment.Provide validation and testing data for new methods and technologies for internal advocacy and external regulatory submission.Facilitate method transfer, validation, and implementation of new microbiology technologies at secondary commercial sites.Adhere to GMP standards and safe laboratory practices. If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at (+1) or

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

INDSCIC

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