24 days old

Microbiologist Laboratory Analyst _ O'Fallon, MO

Kelly Services
O'Fallon, MO 63368
**Microbiologist Laboratory Associate / OFallon, MO**

Kelly Services is currently seeking a Microbiologist Laboratory Associate for one of our top clients in OFallon, MO

As a Microbiologist Laboratory Associate placed with Kelly Services you will be responsible for providing technical expertise and practical execution of all activities associated with Microbiology and Sterilization to support manufacture of terminally sterilized pharmaceutical products. This position is currently listed through the end of the year with an expected extension.

**Job Requirements:**

+ Serve as microbiology and sterilization subject matter expert for Quality Assurance activities, manufacturing operations and projects

+ 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

+ Contribute strategically, tactically and practically to ensure cGMP compliance of products and processes

+ 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)


+ 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

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

+ 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. 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

+ 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. Call 423-337-1505 for questions about the position but please apply on line to be considered for the position.

**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

+ Career guides, information and tools to help you successfully position yourself throughout every stage of your career

+ Access to more than 3,000 online training courses through our Kelly Learning Center

+ Weekly pay and service bonus plans

+ Group-rate insurance options available immediately upon hire

**Apply Today!**

_*Available for purchase and administered by a designated third-party vendor_


**Why Kelly** **** **?**

With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at
Posted: 2019-10-18 Expires: 2019-11-18

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Microbiologist Laboratory Analyst _ O'Fallon, MO

Kelly Services
O'Fallon, MO 63368

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