Lead Scientist- QC

Lead Scientist- QC Apply Now Applied To save a job sign in or get started

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10158580 Posted today Back Raritan, NJ, US Scientific Bachelors Degree Full Time, Temporary $50.00- $60.00 Experienced (Non-Manager) On-site Biotechnology/Pharmaceuticals First Shift (Day) Raritan, NJ, US $50.00- $60.00 Experienced (Non-Manager) Full Time, Temporary Biotechnology/Pharmaceuticals On-site Scientific Bachelors Degree First Shift (Day) Apply Now Applied Job details Lead Scientist- QC, Pharmaceutical About the role: This role is responsible for performing quality control laboratory testing (60%) and document review, investigations, and CAPA management (40%) within a pharmaceutical manufacturing environment. The position involves routine testing and analysis of finished products (tablets, capsules, soft gels) and raw materials, using a variety of analytical techniques and instrumentation. A key component of this role is leading laboratory investigations, including deviations and out-of-specification (OOS) results, as well as authoring detailed investigation reports and supporting CAPA closure activities. The ideal candidate will have strong experience in technical writing, data review, and quality systems such as TrackWise and MasterControl, along with a solid background in oral solid dosage forms and GMP compliance. Key Responsibilities QC Laboratory Testing (60%) Perform routine testing and analysis of raw materials, in-process samples, and finished products. Conduct assays and analytical tests including identity (ID), content uniformity, blending uniformity, impurity testing, water content (Karl Fischer), disintegration, and hardness. Execute stability testing under ICH conditions and evaluate product performance over time. Operate, maintain, and troubleshoot analytical instruments including HPLC, UPLC, GC, FTIR, Karl Fischer, pH meters, and dissolution/visualization testers. Utilize Empower 3 or similar chromatography software for data acquisition and processing. Ensure all testing is performed in accordance with SOPs, USP monographs, and GMP regulations. Investigations, Documentation & CAPA (40%) Lead laboratory investigations related to deviations, OOS, OOT, and non-conformances. Author clear, thorough, and compliant investigation reports, including root cause analysis and corrective actions. Manage and close CAPAs, ensuring timely and effective resolution. Perform document review and data verification, ensuring accuracy, completeness, and compliance. Utilize quality systems such as TrackWise and MasterControl to initiate, track, and lead investigations. Collaborate cross-functionally with QA, manufacturing, and other departments to resolve quality issues. Support audit readiness by maintaining well-documented and compliant records. Additional Responsibilities Conduct peer data review and trending analysis to identify potential quality issues. Assist with calibration, maintenance, and general laboratory operations. Support continuous improvement initiatives related to laboratory processes and compliance. Education & Experience Bachelor's degree in Chemistry or related scientific field. 10-15 years of pharmaceutical QC experience, preferably with oral solid dosage forms and raw materials. Strong background in GMP-regulated environments and USP testing methods. Required Skills Proven ability to lead investigations (OOS, deviations, CAPAs) from initiation through closure. Strong technical writing skills, with experience authoring investigation reports and quality documentation. Hands-on experience with TrackWise and MasterControl, including leading investigations within these systems.

Expertise in analytical instrumentation:

HPLC, UPLC, GC, FTIR, Karl Fischer. Experience with Empower 3 or similar chromatography software. Strong knowledge of data integrity, documentation practices, and regulatory compliance. Ability to analyze data, identify root causes, and implement corrective actions. Excellent organizational, communication, and cross-functional collaboration skills. 10158580 Share this job Copied url To save a job sign in or get started To apply for this job email your details to I want more jobs like this in my inbox.

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Share this job Copied url Link Copied Similar Jobs To save a job sign in or get started Scientist Hoboken, NJ, US Full Time, Temporary $50.00- $60.00 To save a job sign in or get started QC Chemist Bronx, NY, US Full Time, Temporary $50.00- $60.00 To save a job sign in or get started Scientist (Next-Generation Sequencing) Spring House, PA, US Full Time, Temporary $50.00- $60.00 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.