A Quality Control Analyst, in the biotech and medical device industries, works in laboratories performing biological, microbiological, and chemical tests on products and materials. Responsible for calibrating equipment, inspecting products, processing and testing materials, and reporting results. May work in other production environments to monitor and improve quality and efficiency in production systems and products.
7:30am•5pm, M-F (some weekends, rotates, rare) Overview Pharmaceutical Company in Bethlehem, PA is seeking an experienced QC Analyst to join their team. In this role, you will be conducting analytical testing that safeguards product integrity, drives quality excellence, and supports regulatory compliance. Responsibilities Perform analytical testing and release of in-process materials, bulk drug substance, finished drug product, and stability samples Sample, inspect, and test raw materials, API, and packaging components Operate, calibrate, and troubleshoot analytical laboratory equipment including GC, UV/Vis, IR, Karl Fischer, ICP/MS, and other QC instrumentation Complete laboratory documentation in accordance with cGMP requirements and assist with OOS, questionable-result, and laboratory-deviation investigations Perform peer review of raw analytical data and support routine stability and QC laboratory activities Requirements Hands-on pharmaceutical Quality Control laboratory experience in a cGMP environment Analytical testing experience with GC and other common QC instrumentation; experience with UV/Vis, IR, Karl Fischer, potentiometer, refractometer, density meter, and ICP/MS Experience testing raw materials/API, in-process materials, finished drug product, and/or stability samples Strong cGMP documentation practices; experience with OOS/laboratory deviations, investigations, and raw analytical data review preferred Bachelor's Degree in a scientific discipline or Associate's Degree in a relevant science, with Chemistry or closely related laboratory science preferred 3+ years of relevant industry experience; pharmaceutical manufacturing / GMP-regulated laboratory experience strongly preferred Experience in sterile pharmaceutical, injectable, API, or finished drug product environments is a plus Detail-oriented, reliable, excellent documentation habits, strong critical-thinking, able to work independently, and effective communication skills System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. #M-3
