Analytical Chemist
4 days ago
Lake Forest
Job Description Job Title: Analytical Chemist Job Description We are seeking an experienced Analytical Chemist to support advanced analytical testing and quality functions within a regulated medical device and pharmaceutical environment. In this role, you will develop, validate, and execute analytical methods, ensure compliance with regulatory standards, and collaborate closely with quality and chemistry teams to maintain the highest levels of product integrity and reliability. Responsibilities • Perform complex chemical analyses on raw materials, intermediates, and finished products using techniques such as HPLC, GC, UV-Vis, FTIR, and ICP-MS., • Develop, validate, and optimize analytical test methods to ensure precision, accuracy, reproducibility, and robustness., • Validate and verify the accuracy of test results in compliance with regulatory and internal quality standards., • Conduct robustness studies and update analytical methods in alignment with industry standards such as ICH, USP, and ISO., • Ensure all laboratory practices comply with GMP, GLP, and applicable regulatory requirements., • Support quality audits and regulatory inspections by providing documentation, data, and analytical expertise., • Prepare detailed technical reports, including Certificates of Analysis (CoAs), validation protocols, and trend analyses., • Accurately document all analyses and quality checks in laboratory records while adhering to data integrity guidelines., • Oversee routine calibration, preventive maintenance, and qualification of laboratory instruments and equipment., • Contribute to risk assessments, corrective and preventive actions (CAPAs), and root cause investigations related to analytical and quality issues., • Bachelor’s degree in Chemistry, Analytical Chemistry, or a related scientific field., • At least 3 years of experience in analytical chemistry and analytical method development., • Hands-on experience in the medical device or pharmaceutical industry., • Proven expertise in analytical techniques including HPLC, GC, UV-Vis, FTIR, and ICP-MS., • Strong experience in analytical chemistry, method validation, and test method development., • Solid understanding of quality systems and regulatory expectations in a GMP/GLP environment., • Proficiency with laboratory information management systems (LIMS) and related laboratory data systems., • Ability to generate and review technical documentation such as validation protocols, CoAs, and analytical reports., • Experience conducting method robustness studies in accordance with ICH, USP, and ISO guidelines., • Familiarity with risk assessments, CAPA processes, and root cause investigation methodologies., • Ability to work effectively with cross-functional teams in quality and laboratory settings., • Strong problem-solving skills and the ability to troubleshoot analytical methods and instrumentation. This is a full-time, onsite laboratory position with a typical schedule of Monday through Friday, 8:00 a.m. to 5:00 p.m. You will work in a regulated laboratory environment alongside cross-functional teams in the lab and quality departments, using advanced analytical instruments such as HPLC, GC, UV-Vis, FTIR, and ICP-MS, as well as LIMS and other laboratory data systems. Job Type & Location This is a Permanent position based out of Lake Forest, CA. Pay and Benefits The pay range for this position is $140000.00 - $160000.00/yr. 401k Dental vision medical PTO/ Holiday/ Sick Workplace Type This is a fully onsite position in Lake Forest,CA. Application Deadline This position is anticipated to close on May 4, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through: • Hiring diverse talent, • Maintaining an inclusive environment through persistent self-reflection, • Building a culture of care, engagement, and recognition with clear outcomes Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.