QC Bioanalytical Scientist Job Listing at Kelly Services in Morris Plains, NJ (Job ID US3527505_BH9703551)

Description

Job Title: QC Bioanalytical Scientist
Location: Parsippany, NJ
Job Summary:
We are seeking a highly motivated and detail-oriented QC Bioanalytical Scientist to perform laboratory method validation, qualification, and transfer activities. The ideal candidate will have experience in cell-based assays, flow cytometry, and drug substance PCR identification. The QC Bioanalytical Scientist will work independently and collaborate with senior team members to ensure successful method qualification, assay transfer, and routine bioanalytical testing.
Key Responsibilities:

• Perform method qualification and participate in bioanalytical assay transfer to ensure the successful start-up of the QC laboratory.
• Conduct compendia method qualifications related to cell-based test assays and flow cytometry. Perform routine analysis of cell culture media, reagents, and cultured cells in-process.
• Utilize analytical methods such as flow cytometry, qPCR, ELISA, and cell viability assays for bioanalytical testing.
• Manage routine instrument maintenance, calibration, and troubleshooting of lab equipment. Generate data entry and result reports in the LIMS system, ensuring accuracy and timeliness.
• Monitor instruments for preventative maintenance and ensure conformance to specifications. Ensure IQ/OQ/PQ of newly purchased instruments are completed by the vendor in a timely manner.
• Conduct thorough investigations for any lab event/OOS/OOT/OOE results in the Trackwise system.
• Perform routine QC responsibilities, including sample aliquoting, lab equipment maintenance, QC document management, inventory control, and reconciliation of sample requests/documents.
• Generate and revise general procedures, protocols, and technical reports as needed.
• Author test methods and specifications, ensuring accuracy and compliance with SOPs.
• Initiate and complete QA-Track records as required.
• Oversee laboratory equipment to maintain optimal temperature and humidity levels, ensuring consistent gas supplies for cell culture facilities.

Required Education/Qualifications/Skills:

• Bachelor's or master's degree in biology, Cell Biology, Immunology, Health Sciences, or a related field from an accredited institution.
• Minimum of 2 years of working knowledge in GMP, QC Analytical, or biotechnology/pharmaceutical industry.
• Familiarity with Standard Operating Procedures (SOPs), cell biology, flow cytometry, analytical test methods, and generally accepted laboratory practices.
• Comfortable working in a cell culture lab area and with viral-based gene-therapy drugs.
• Experience with LIMS and Trackwise is a plus.

Required Competencies (Behavioral Indicators):

• Strong verbal and written communication skills with the ability to convey complex ideas and concepts.
• Exceptional attention to detail, particularly in reviewing documentation for adherence to SOP format requirements and accurate data entry.
• Flexibility in work schedule and ability to adapt to changing priorities.
• Ability to effectively negotiate and influence key partners and suppliers to meet requirements and commitments.
• Capability to train and mentor colleagues, fostering a collaborative work environment.
• Drive for results and the ability to work under minimal supervision.

 

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. 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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