QC Analyst I

Company: Actalent
Location: Newark
Posted on: March 17, 2023

Job Description:

Description:The QC Analyst I of analytical team will be responsible for testing of in-process, lot release, stability samples and critical reagents for various commercial and clinical drug products. Author and revise SOPs, deviations, CRs and LIRs. Areas of responsibility include but are not limited to testing samples for molecular biology techniques such as water content, ELISA, western blot, SDS-PAGE and/or analytical chemistry techniques such as SEC-HPLC, CEX-HPLC, IEX HPLC as needed. Actively participate in group and project teamwork. Support in preparing the lab documentation and lab readiness for Health Authority Inspection.ESSENTIAL DUTIES--- Perform routine and non-routine release, in-process and stability testing for drug substance, drug product, and other critical reagents and documentation under cGMP.--- Perform Analytical assays such as ELISA, SDS-PAGE, Western Blot, Water Content, and chromatography assays (SEC, CEX and IEX HPLC)--- Author and lead quality records such as Deviation, Lab Investigations, CAPA, Change Control including leading thorough and timely investigation and/or implementation activities. --- Author and revise SOPs as needed--- Review of laboratory records generated in support of QC testing including procedures, methods, audit trails and other controlled documents. --- Compile and review data to ensure accuracy and regulatory compliance.--- Support sample receiving, shipment to contract lab and inventory of sample.--- Work collaboratively with Manufacturing, QA and Regulatory to support CMC analytical deliverables.Skills:Quality control, sds page, western blot, assay, hplcTop Skills Details:Quality control,sds page,western blot,assayAdditional Skills & Qualifications:EDUCATIONMinimum Required: --- Bachelor's in Biochemistry, Chemistry or related sciences. EXPERIENCE--- A minimum of 2 years in in a Quality Control laboratory environment (GMP environment preferred) in the pharmaceutical or related industry.--- A minimum of 1-2 years of experience with chromatography (SEC, CEX and IEX) and/or electrophoresis (Western blot and SDS-PAGE) and ELISA are required.--- Knowledge of basic analytical testing such as Karl Fisher (water content), Appearance, pH, UV is preferred. --- Hands on experience in BSL-3 laboratories is a plus. About Actalent: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Actalent, Newark , QC Analyst I, Professions , Newark, California