Company: Spectraforce Technologies Inc
Posted on: January 10, 2022
Job title: Scientist I, Manufacturing Sciences
Duration: 6 Months
Location: Fremont, CA
Manufactures products for the Bulk Formulations Toxicology team and
completes associated cGMP documentation. Works with chemicals and
biologicals to manufacture reagents, calibrators, and controls for
IVD immunoassay use. Participates in projects to drive process
Manufacture products including reagents, calibrators, buffers,
controls, etc. and complete batch records while maintaining cGMPs
and GDP standards.
Perform in-process testing using clinical analyzers and analyze raw
data for in-process adjustments and product release.
Review other manufacturing operators/scientist's batch records.
Maintain and analyzes lot histories for trends and
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.
May modify SOPs, work instructions and reports with mentorship.
Initiate and support investigations for quality documentation
including NCARS, CAPAs, and Variances.
Maintain and troubleshoot testing and formulations equipment as
Keep department supervisor and/or manager updated on all issues
Perform other job duties as the need arises.
BS/BA in scientific field (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.
Must be able to lift 25 lbs routinely
Preferred Hiring Criteria:
Must be organized and detail oriented to prioritize own and other's
work and meet business efficiency metrics with great
Self-sufficient, self-motivated, and focused
IVD immunoassay manufacturing experience preferred
General laboratory skills 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
Keywords: Spectraforce Technologies Inc, Fremont , Scientist, Other , Fremont, California
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