**QC Scientist I (Bioassay)**28-31/HR

**QC Scientist I (Bioassay)**28-31/HR

Empresa: Actalent. Job Title: QC Scientist I (Bioassay) Job Description The QC Scientist I (Bioassay) supports Good Manufacturing Practice (GMP) manufacturing by performing analytical testing for commercial products and stability studies in a cGMP laboratory environment. You will use a range of analytical tools for large molecule analysis, including compendial methods, enzyme activity assays, and bioassays, to ensure timely and accurate testing of in-process, drug substance release, and stability samples. This role offers structured training, exposure to advanced analytical technologies, and the opportunity to grow within a collaborative, development-focused culture. Responsibilities - Perform ELISA, compendial testing (pH, UV, osmolality, appearance), enzyme activity assays (including temperature and incubation parameters), and other bioassays on in-process, drug substance release, and stability samples to support GMP manufacturing and stability programs. - Operate analytical instruments such as spectrometers, plate readers, and other minor laboratory equipment to execute assigned test methods accurately and efficiently. - Conduct GMP testing in an analytical laboratory using HPLC and UPLC methods, including reverse phase, size-exclusion chromatography (SEC), concentration measurements, cation-exchange chromatography (CEX), and related techniques. - Compile, analyze, and interpret test data, document results according to Standard Operating Procedures, and prepare clear and accurate reports. - Review laboratory data packets as assigned to ensure completeness, accuracy, and compliance with applicable procedures and regulations. - Perform and author laboratory investigations, including out-of-specification (OOS) and out-of-trend (OOT) assessments, as assigned by laboratory leadership. - Recognize and promptly report invalid results, laboratory incidents, and out-of-specification or out-of-trend results to laboratory management, and recommend appropriate corrective ac