QC Microbiologist

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) 267-846-2026 or j.cerchio@proclinical.com.

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