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Formulations Scientist

Company: Astrix Technology Group
Location: Fremont
Posted on: May 3, 2021

Job Description:

What will you do?Manufacture products and complete batch records following cGMPS including calibrators, buffers, controls, etc.Perform in-process testing using clinical analyzers. Review and analyze data.Review other manufacturing operators/scientists batch records.Maintain and analyzes lot histories for trends and discrepancies.Weigh, transfer, and mix required chemicalsPerform product filtrationsParticipate in process improvement projects to improve efficiencies and support business needs.May modify SOPs, work instructions and reports with guidance.Initiate and support investigations for nonconformances and deviationsMaintain and troubleshoot equipment as appropriate.Keep department supervisor and/or manager updated on all issuesPerform other job duties as required.How will you get here?High school diploma or equivalent required.BS/BA in scientific discipline (Chemistry or Biochemistry preferred) with 0-2 years related experience and/or training preferred. Equivalent combination of education and years of related experience may be substituted.IVD manufacturing experience is a plus.Knowledge, Skills, AbilitiesLaboratory skills and knowledge of safety precautions is a plusExperience in working with potentially hazardous chemicals and human source materials is a plusFamiliarity with Quality System Regulations and ISO 13485 regulations is a plusMust be able to lift 25 lbs. routinelyMust perform tasks in compliance with GMP, GDP, QSRs, ISO and IVD regulationsStrong laboratory skills including pipetting, safety, and hazardous chemical handlingMust be organized and detail oriented to be able to prioritize own and others work and meet business productivity metricsSelf-sufficient, self-motivated, and focused

Keywords: Astrix Technology Group, Fremont , Formulations Scientist, Other , Fremont, California

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