QC Microbiologist Job Listing at Kelly Services in Hackensack, NJ (Job ID 9452874)

Description

Job Title: Senior Scientist, Microbiology
Job Description: We are seeking a highly skilled Senior Scientist specializing in Microbiology to lead and actively participate in the experimental design, method validation/qualification, and technical transfer activities for compendial methods across raw materials and finished products. As a pivotal member of our Quality Control team, you will perform both routine and non-routine testing, ensuring adherence to cGMP guidelines and leveraging lean six sigma principles for continuous improvement.
Key Responsibilities:

• Lead experimental design, compendia method qualifications, and assay transfers to ensure seamless project execution in the laboratory.
• Execute a variety of microbiological methods including Bioburden testing, Sterility Testing, and Microbial Limits Testing.
• Manage the stability program from sample pulling through testing, submission to external labs, and report generation.
• Train new hires and assist junior analysts in water and environmental sampling, gown qualification, and media fills.
• Oversee environmental performance qualifications for new cleanroom areas, conducting risk assessments and developing sampling plans.
• Analyze and interpret results, ensuring accuracy, completeness, and compliance with regulatory requirements.
• Configure new analyses, products, and specifications in LIMS, liaising with vendors for laboratory needs.
• Author and review GMP data, including SOPs, test methods, validation protocols/reports, and technical reports.
• Monitor lifecycle of microbiology instruments, ensuring calibration and maintenance conform to specifications.
• Manage QC document archival and inventory control of consumables, media, and garments.
• Issue deviations, conduct laboratory investigations, and implement corrective actions in LIMS and QA-Track.
• Develop and deliver training programs for junior analysts and Micro Associates on technical concepts and methods.

Requirements:

• Bachelor of Science Degree in Biological or Environmental Sciences required; Master of Science degree preferred.
• Minimum 8 years of QC laboratory experience in pharmaceutical or biopharmaceutical industry with Bachelor's Degree, or 4 years with Master's degree.
• Strong preference for experience in Cell/Gene Therapy, Cell-Based Assays, and Rapid Microbial Methods.
• Expertise in SOPs, analytical test methods, and laboratory practices.
• Knowledge of USP/EP/cGMP and ICH guidelines, microbiology techniques, and LIMS.

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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's 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.

 Apply on company website