QC Mircrobiologist

Alphanumeric is hiring a QC Microbiologist to work in Rockville, MD with our client of 20 years committed to improving lives through medical and pharmaceutical advancements.

DURATION: THROUGH 2024 (Most likely extended through the end of 2026)

100% ON SITE

PAY: $40 - 42.50 hourly

Seeking an Expert Scientist in Quality Control Microbiology with experience or specialty in endotoxin detection methods. This is an exciting and unique role where the applicant will have the opportunity to implement novel technology into biological and pharmaceutical products and processes.

Responsibilities

Drive implementation of new and rapid microbiology technologies that ensure data integrity, meet quality standards, and support regulatory submissions and delivery of quality medicines for patients.

* Design and execute method development and GMP validation for recombinant factor C endotoxin testing.
* Contribute to method development and method qualification.
* Perform laboratory operations to support and implementation of compliant, state of art methodology and instrumentation.
* Provide scientific understanding and analytical support for development of new test method, validation, and specifications.
* Support for scientific report writing and document revision.
* Provide analytical troubleshooting support for investigations which require non routine/specialized service.
* Support microbiology technology validation and implementation for testing pharmaceutical products and manufacturing environment.
* Provide validation and testing data for these 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.
* Work to GMP standards as appropriate.
* Follow safe Laboratory Practices, regular safety training, and maintain accurate and complete safety records consistent with company policy and legal requirements.