Overview

Job Description Job Description Essential Duties and ResponsibilitiesThis is a second shift role that operates between 4:00 pm to 1:00 am, Sunday through ThursdayWith no instruction on routine work and general instructions on new assignments, perform Quality Control laboratory activities to support pharmaceutical CDMO testing, release, stability, raw material, in-process, and client project needs.Apply professional scientific concepts, Quality Control laboratory practices, company policies, procedures, safety practices, cGMP/GLP documentation expectations, and data integrity principles to solve a wide range of difficult problems in imaginative and practical ways.Prepare and support preparation of samples, standards, reagents, buffers, mobile phases, solutions, and laboratory materials in accordance with approved procedures, protocols, methods, specifications, or project-specific instructions.Support the quality control laboratory as a co-stability program coordinator by executing of the Gannet Biochem stability program by coordinating, scheduling testing, reporting, and summarization of results in a cGMP capacity.Perform analytical testing and laboratory support activities using established practices and procedures, which may include HPLC/UPLC, GC, UV-Vis, FTIR, titration, Karl Fischer, dissolution, wet chemistry, or other analytical techniques, as assigned and trained.Operate, clean, troubleshoot, maintain, and support readiness of laboratory equipment and analytical instrumentation in accordance with SOPs, work instructions, equipment use logs, and applicable safety requirements.Analyze simple data, identify obvious trends, review chromatograms, calculations, observations, and laboratory results, and escalate unexpected results or technical issues appropriately.Accurately document laboratory work, observations, calculations, instrument use, sample preparation, test results, deviations from expected results, and other required information in notebooks, worksheets, forms, electronic systems, or approved records.Compile, summarize, and communicate analytical data, observations, conclusions, task status, and supporting information for review by senior analysts, scientists, project teams, Quality, clients, or management.Follow approved test methods, specifications, SOPs, protocols, safety procedures, and laboratory controls; exercise judgment within generally defined practices and policies and seek direction when appropriate.Support investigations, deviations, out-of-specification or atypical result evaluations, change controls, CAPAs, laboratory troubleshooting, technical reports, and client deliverables by gathering, evaluating, and organizing data, records, observations, and supporting documentation.Draft, review, or revise laboratory documentation, including test methods, protocols, worksheets, reports, SOPs, forms, or other controlled documents, as assigned.Train others on simple laboratory tasks, procedures, documentation practices, equipment use, or workflow expectations, as assigned.Work with Quality Control, Analytical Development, Process Development, Manufacturing, Quality Assurance, and other internal teams to support timely completion of assigned tasks.Maintain laboratory supplies, standards, reagents, samples, retain materials, reference materials, and inventory records in accordance with company procedures.Maintain a clean, safe, and organized laboratory work area and comply with applicable company safety, environmental, quality, regulatory, and confidentiality requirements.Perform other duties as assigned.Minimum Qualification RequirementsBachelor's degree in Chemistry, Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, Life Sciences, or a related scientific field required.Minimum two (2) years of cGMP/cGLP related experience required; experience in Quality Control, analytical testing, pharmaceutical development, CDMO operations, analytical development, or a regulated laboratory env