
Description
Microbiology Team Lead, OTC
Toledo, OH area
Relocation Assistance
Full Benefits/Perks
Target Salary: $70-80K
About the Role:
Microbiology Team Lead will be responsible for microbiological testing, ensuring that our diverse portfolio of products—including FDA-regulated OTC drugs, EPA-registered disinfectants, and cosmetics—meets the highest standards of safety and efficacy.
You will be a key player in maintaining the hygienic integrity of our facility, validating new methods, and leading a team committed to excellence.
Key Responsibilities:
- Lead Quality & Regulatory Compliance: You will be the guardian of our microbiological standards, ensuring full compliance with cGMP, GLP, and ISO guidelines. This includes establishing and maintaining microbial alert and action limits, preparing for and supporting internal and external audits (including FDA), and meticulously reviewing records for accuracy and compliance.
- Drive Problem-Solving and Improvement: Take ownership of Out-of-Specification (OOS) investigations and deviations. You will conduct thorough root cause analyses and implement effective corrective actions to resolve issues and improve processes. You will also stay ahead of industry trends and new technologies, recommending and implementing improvements to our microbial hygiene practices.
- Direct Hands-On Expertise: Apply your deep knowledge of microbiological techniques, including aseptic practices, microbial enumeration, and identification methods. You will conduct critical testing on raw materials, in-process samples, and finished products, as well as perform environmental monitoring of our manufacturing and cleanroom areas.
- Execute Technical Protocols: This role requires the ability to write and execute microbiological validation protocols and conduct key studies such as preservative efficacy testing and disinfectant efficacy studies. You will ensure all testing and documentation align with USP methods and regulatory requirements.
- Bachelor's degree in Microbiology, Biology, or a related scientific field; an advanced degree is preferred.
- 5–10 years of experience in Quality Control Microbiology, preferably within the pharmaceutical, cosmetic, or a related regulated industry.
- 3–5 years of hands-on microbiology experience in a manufacturing environment.
- Strong proficiency in core microbiological techniques and a comprehensive understanding of regulatory guidelines from the FDA, EPA, and other relevant agencies.
- Demonstrated ability to write and execute validation protocols.
- Must be able to stand for long periods at a time.
- Must be able to lift at least 50 pounds.
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.
Apply on company website