QC Microbiologist - Contract - Rockville, MD

Proclinical is seeking a dedicated and skilled QC Microbiologist. This is a contract role located in Rockville, MD.

Primary Responsibilities:

The ideal candidate will be responsible for implementing new and rapid microbiology technologies to ensure data integrity, quality standards, and support regulatory submissions for quality medicines. They will design and execute method development and GMP validation for recombinant factor C endotoxin testing while performing laboratory operations to support advanced methodologies and instrumentation. With a strong background in method development, validation, and qualification, they will provide scientific expertise and analytical support for developing new test methods and specifications.

Skills & Requirements:

Bachelor's degree in Biological Sciences or a related field (e.g., Microbiology, Biochemistry).Over three years of experience in research, analytical development, and/or quality control.Proven experience and solid working knowledge in method development and method validation/qualification.Experience with GMP laboratory operations.Hands-on experience with endotoxin detection using chromogenic methods for pharmaceutical products and/or water.Strong scientific understanding and ability to support the development of new test methods, validations, and specifications.Knowledge of biological and pharmaceutical product manufacturing and microbial control.Familiarity with FDA regulations.

The QC Microbiologist will:

Implement new and rapid microbiology technologies to ensure data integrity, meet quality standards, and support regulatory submissions for delivering quality medicines.Design and execute method development and GMP validation for recombinant factor C endotoxin testing.Develop and qualify new test methods.Perform laboratory operations to support the implementation of compliant, advanced methodologies and instrumentation.Provide scientific expertise and analytical support for developing new test methods, validations, and specifications.Contribute to scientific report writing and document revisions.Offer analytical troubleshooting support for specialized investigations.Validate and implement microbiology technologies for testing pharmaceutical products and the manufacturing environment.Provide validation and testing data for internal advocacy and regulatory submissions.Ensure safe laboratory practices, participate in regular safety training, and maintain accurate safety records in accordance with company policy and legal requirements.

If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at (+1) 215-531-6914 or s.briggs@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