Kelly Services Microbiologist in O'Fallon, Missouri

Kelly Services has provided outstanding employment opportunities to the most talented professionals in the marketplace. Today, we are proud to offer an excellent contract opportunity for a Microbiologist for a medical device company in O'Fallon, Mo.

Microbiologist

Quality Assurance will provide technical expertise and practical execution of all activities associated with Microbiology and Sterilization to support manufacture of terminally sterilized pharmaceutical products. Position will serve as microbiology and sterilization subject matter expert for Quality Assurance activities, manufacturing operations and projects. Position will engage collaboratively and cross-functionally with other departments to provide microbiological support for activities associated with quality assurance, production, sterilization, facilities maintenance and engineering, method and process validation, product and process development. The incumbent shall contribute strategically, tactically and practically to ensure cGMP compliance of products and processes.

Responsibilities:

  • Provide microbiological and sterilization expertise to establish, maintain and continually improve quality control and assurance programs for manufacture of terminally sterilized pharmaceutical products. Relevant programs and activities may include, but are not limited to:

  • Environmental monitoring

  • Sterility assurance, including sterilizer cycle development and validation, load monitoring, product testing and parametric release.

  • Bioburden monitoring

  • Cleaning and disinfection, including validation of cleaning and disinfection processes.

  • Establishing hold times for terminally sterilized solutions.

  • Development and validation of microbiological analytical methods.

  • Stability

  • Particulate matter control

  • Container-closure / packaging integrity

  • Quality investigations

  • Author and review procedures, protocols, reports, investigations and relevant sources of information to ensure that microbiology sampling, test methods and quality assurance programs are consistent with current industry practices and regulatory requirements.

  • Coordinate and perform method development, validation and testing with support from internal and external microbiology laboratories for process quality, product release and project testing.

  • Author and review test protocols/data/reports for validating new products and processes to ensure conformance with established specifications and related standard operating procedures.

  • Anticipate /evaluate technical problems and provide recommendations for corrective actions.

  • Write, collect, organize and compile data and reports for use by upper management and to comply with regulatory requirements.

  • Interface with pertinent disciplines to establish, maintain and continually improve test methods and quality assurance programs.

  • Review and/or develop specifications for raw materials, components and finished products.

  • Evaluate, specify and justify Microbiology and Sterilization requirements for process improvement, major capital and other projects.

  • Represent company on microbiology and sterilization topics during interactions with regulatory agencies, including interface with FDA inspectors.

  • Participate on cross-functional teams to resolve issues.

  • Coordinate microbiology and sterilization validation programs for new products (including changes to containers, closures or solutions).

  • Expertise: Knowledge & Skills

  • A strong scientific knowledge in areas pertaining sterilization approaches and processes (moist heat, sterility assurance, bioburden control, load monitoring).

  • Knowledge of environmental, utility and facility monitoring programs, including area classifications. Familiarity with equipment installation and qualification and electronic data systems. Awareness of general cost structure pertinent to microbiological testing and validation.

  • Strong problem solving and troubleshooting capabilities. Good written and verbal business communication skills. Must be able to work productively and cooperatively in a cross-disciplinary environment.

Qualifications - Experience/Training/Education/Etc

Required: Degree in Microbiology, Molecular Biology, Biochemistry or a related science with significant microbiology coursework.

  • Pharmaceutical / medical device industry experience, 2 years in a cGMP environment.

  • Strong technical expertise in areas related to: sterility testing, bioburden, endotoxin, cleaning & disinfection, method validation, particulate matter, and biological indicators (manufacturing, testing & use).

  • Demonstrated industry experience in several of the following areas: microbiological method development and validation, D&z value determination, cycle time reduction (CTR) studies, container-closure / packaging integrity testing (including microbial ingress, dye penetration or other methods).

  • Experience in qualification of raw materials and components used in GMP manufacturing. Generation of microbiological specifications and programs in alignment with requirements and current standard practices.

  • Hands-on experience in addressing microbiology and sterilization related topics in regulatory submissions. Experience interacting with regulatory agencies.

  • Desired:Bachelor’s degree in relevant field

  • Experience with manufacturing and quality assurance of ethylene oxide terminally sterilized medical devices.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.

Why Kelly?

  • As a Kelly Services employee, you will have access to numerous perks, including:

  • Exposure to a variety of career opportunities as a result of our expansive network of client companies

  • A competitive hourly pay rate with weekly checks

  • Access to newly expanded Medical Plan options

  • Online continuing education via the Kelly Learning Center

  • Several employee discounts

Why Kelly ® ?

At Kelly

Services ® , we work with the best. Our clients include 95 of the Fortune

100 ™ companies, and more than 70,000 hiring managers rely on Kelly annually to access

the best talent to drive their business forward. If you only make one career connection today, connect

with Kelly.

AboutKelly Services ®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people

around the world and have a role in connecting thousands more with work through our global network of

talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,

Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is

committed to employing a diverse workforce. Equal Employment Opportunity

is The Law.