
Description
Microbiologist II
Job Duties
- Carries out the practical work in the laboratory including method development, method validation and trouble shooting.
- Takes over responsibility for the QC part of projects.
- Perform required testing on raw materials, intermediates and finished products.
- Support QC chemist to provide the method technology transfer and project preparation work, make sure the project runs on time and smoothly.
Key Accountabilities
- Performs, analyzes, and interprets QC and microbial limits testing according to USP and regulatory requirements for raw materials, finished products, and stability samples.
- Perform environmental monitoring which includes water sampling and testing.
- Performs microbiology methods and sampling techniques.
- Performs investigations and completes CAPA in response to laboratory investigations.
- Manages change controls effectively.
- Manages/ supports microbiology projects from production or formulations development dept.
- Actively participates in customer and regulatory audits as area SME.
- Develops and executes validation protocols for test methods and equipment qualification.
- Author and review SOPs and test methods related to microbiology.
- Ensure the microbiological integrity of environment, equipment and facilities.
- Manages product testing based upon internal and customer specifications.
- Managing 3rd party laboratory testing and reporting of data and EM when necessary.
- Report on testing results, including CoA s. Maintain equipment, media, and sample logs as needed.
- Ensure the micro lab is adequately supplied and maintained.
- Perform other responsibilities to support the business as requested.
- Adhere to all defined Safety and Sustainability requirements and expectations and seek clarification whenever Safety and Sustainability requirements and expectations are either unknown or unclear.
- Promptly report identified Safety and Sustainability issues, problems, deficiencies, errors, incidents, and/or opportunities to management and correct where possible.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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