Scientist I, Manufacturing

Integrated Resources, Inc

  • Fremont, CA
  • 10 days ago
  • $25–$30 Per Hour
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Skills

  • Analysis Skillsunmatched
  • Background Investigationunmatched
  • Biochemistryunmatched
  • Business Supportunmatched
  • Calibrationunmatched
  • Chemistryunmatched
  • Cleanroomunmatched
  • Clinical Assessmentunmatched
  • Current Good Manufacturing Practice (cGMP)unmatched
  • Data Analysisunmatched
  • Detail Orientedunmatched
  • Documentationunmatched
  • Establish Prioritiesunmatched
  • GMP (Good Manufacturing Practices)unmatched
  • ISO (International Organization for Standardization)unmatched
  • Immunoassaysunmatched
  • Lift/Move 25 Poundsunmatched
  • Lift/Move 50 Poundsunmatched
  • Maintain Complianceunmatched
  • Manufacturingunmatched
  • Mentoringunmatched
  • Metricsunmatched
  • Operational Improvementunmatched
  • Operational Strategyunmatched
  • Operational Supportunmatched
  • Organizational Skillsunmatched
  • Physical Demandsunmatched
  • Process Improvementunmatched
  • Record Keepingunmatched
  • Regulationsunmatched
  • Regulatory Complianceunmatched
  • Safety Processunmatched
  • Safety/Work Safetyunmatched
  • Standard Operating Procedures (SOP)unmatched
  • Testingunmatched
  • Trend Analysisunmatched

Description

Job Title: Scientist I, Manufacturing
Location: Fremont, CA
Duration: 6 Months+
Pay: $25 to 30/hr. on W2
Shift: Monday to Friday 9am to 5pm


Notes:
May extend or convert after 6 months, based on performance and business needs.

Description: Location/Division Specific Information
Part of Clinical Diagnostics Division of Specialty Diagnostics Group

Client Impactful Work:
  • You will be responsible for manufacturing products for the Bulk Formulations team and complete associated cGMP documentation.
  • You will work with chemicals and biologicals to manufacture reagents, calibrators, and controls for IVD immunoassay use and participate in process improvements projects.
A day in the Life:
  • Manufacture products including reagents, calibrators, buffers, controls, and intermediates, and complete batch records while maintaining cGMPs and GDP
  • Perform in-process testing using clinical analyzers and analyze raw data for in-process adjustments and product release
  • Review of other manufacturing operators/scientist’s batch records
  • Maintain and analyze lot histories for trends and discrepancies
  • Perform laboratory activities including weighing, transferring, and mixing required chemicals and performing product filtration
  • Participate in process improvement projects to improve operational efficiencies and support business needs through 5s and lab clean ups
  • Modify SOPs, work instructions, and reports with mentorship
  • Initiate and support investigations for quality documentation including non-conformances, CAPAs, and Variances
  • Maintain and troubleshoot testing and formulations equipment as appropriate
  • Keep department supervisor and/or manager updated on all issues
  • Perform other job duties as the need arises
Keys to Success:
Education
  • BS/BA in Scientific field in Chemistry, Biochemistry, or related technical discipline; equivalent combination of education and years of related experience may be substituted
Experience:
  • 1+ years of related experience and/or training preferred
  • Laboratory skills, including pipetting, safety, and hazardous chemical handling and knowledge of safety precautions
  • Experience in working with potentially hazardous chemicals and human source materials preferred
  • Familiarity with Quality System Regulations and ISO 13485 regulations is a plus
Knowledge, Skills, Abilities:
  • Ability to perform tasks in compliance with GMP, GDP, QSRs, ISO and IVD regulations
  • Must be organized, detail-oriented, and can prioritize own and other’s work to meet business efficiency metrics
  • Self-sufficient, self-motivated, and focused
Physical Requirements / Work Environment:
  • Controlled Substance Handling: This role involves the handling, management, and oversight of controlled substances. The role will be responsible for ensuring compliance with all relevant regulations and guidelines on controlled substances.
  • Exposure to Controlled Substances: The role may be exposed to controlled substances during their duties. Proper safety protocols and protective measures will be provided and must be strictly followed.
  • Safety Protocols: Ability to adhere to strict safety protocols and procedures to ensure a safe working environment.
  • Background Check: Successful completion of a background check, including screening for any history related to controlled substances.
  • Ability to occasionally lift 50lbs, routinely lift 25lbs


 

Numbers & Facts

LocationFremont, CA
Salary$25–$30 Per Hour

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