Engineer/Scientist QC, Fremont, CA
Company: Kelly Services
Posted on: April 9, 2021
Engineer/Scientist QC, Fremont, CADay ShiftPay Rate: 26/hr
Position Summary: Using standard operating procedures SOP and good
manufacturing practices GMP , the Engineer/Scientist I will perform
Release and Surveillance testing of raw materials, filled bottle
components and finished goods kits.The Engineer/Scientist I will be
responsible for all aspects of laboratory testing, such as sample
receipt, data generation, product verification, data analysis and
summarization, instrument operation, and all other QC lab
supporting activities.Key Responsibilities:
- Conducts analytical and functional testing of finished good
kits and/or filled bottle reagents/calibrators according to
approved SOPs as part of QC Release Surveillance testing.
- Perform testing using chemistry clinical analyzers and document
test results accurately using Excel spreadsheets and
- Perform testing according to established time points and ensure
timelines are met, as required per the standard procedure. Initiate
out of specification investigations, as needed.
- Perform stability testing protocols on newly launched products,
as well as on market products.
- Documents test results, complete batch records, document
problems and other relevant information under cGMPs.
- Perform simple revisions and updates to QCs SOPs and/or
worksheets as necessary, and initiate procedure change orders.
Interpret and summarize test data, maintain lot histories and
evaluate data for trends and discrepancies. Performs other
responsibilities to support the needs of the department as assigned
- Participate in PPI, Lean, and 5S programs, as required.Minimum
- Minimum BS/BA in Chemistry, Biochemistry, or Bioscience with
0-2 yrs Quality Assurance/Quality Control experience, preferably in
the medical diagnostics industry.
- Demonstrated ability and/or additional experience may be
considered in lieu of a BS/BA degree.
- Strong laboratory skills including pipetting, safety, and
hazardous chemical handling.
- Understanding of cGMP and how it applies to the work
environment is preferred. High level of reading comprehension
- Ability to follow written and verbal directions with a high
level of accuracy.
- Must be able to write clear, understandable documentation.
- High level of verbal communication skills.
- Manual dexterity, must be able to lift/move up to 20
- Intermediate word processing and spreadsheet software
- Ability to manage multiple tasks simultaneously.
- Ability to work independently.
- Ability to perform simple data analysis and to summarize
- Basic math skills including calculation of concentrations and
dilutions and a strong grasp of algebraic concepts.Why
Kelly--?Kelly Science & Clinical is your connection to premier
scientific and clinical companies looking to hire talented people
just like you. Every day, we match science professionals with dream
jobs that fit their skills and interests-it's the way we think job
searching should be. Nearly 100 percent of our science recruiters
have a professional background/education in science, so we know a
thing or two about the science market and how to get you
noticed.About Kelly--At Kelly, we're always thinking about what's
next and advising job seekers on new ways of working to reach their
full potential. In fact, we're a leading advocate for
temporary/nontraditional workstyles, because we believe they allow
flexibility and tremendous growth opportunities that enable a
better way to work and live. Connecting great people with great
companies is what we do best, and our employment opportunities span
a wide variety of workstyles, skill levels, and industries around
the world. Kelly is an equal opportunity employer committed to
employing a diverse workforce, including, but not limited to,
minorities, females, individuals with disabilities, protected
veterans, sexual orientation, gender identity. Equal Employment
Opportunity is The Law.]]
Keywords: Kelly Services, Hayward , Engineer/Scientist QC, Fremont, CA, Other , Hayward, California
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