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
Location
Fremont, CA
Salary
$25–$30 Per Hour
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
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