Engineer Scientist I / QC

Integrated Resources, Inc
Published
December 31, 2020
Location
Fremont, CA
Category
Job Type

Description

Title: : Engineer Scientist I / QC

Location: Fremont, CA 94538

Duration:  5 Months

 

Job Description:

How will you make an impact?

  • The Engineer/Scientist will use Standard Operating Procedures (SOP) and Good Manufacturing Practices (GMP) to will perform routine testing of raw materials.
  • Be responsible for multiple aspects of laboratory operations, such as sample receipt, data generation, material testing, data analysis and summarization, out-of-specification investigations, instrument qualifications, and other QC lab supporting activities.

What will you do?

  • Perform routine testing and analysis of raw materials according to established Quality Control procedures using different instrument platforms.
  • Document test results, complete batch records, document problems and other relevant information under cGMPs.
  • Maintain and analyze lot histories for trends and discrepancies.
  • Perform initial review on departmental paperwork; completed batch records.
  • Perform initial troubleshooting of issues which arise during routine analysis, perform out of specification (OOS investigations) and if needed, initiate non-conformance (NCAR) reports.
  • Initiate OOS, NCARs and Variances, as required.
  • Perform initial troubleshooting of issues which arise during routine analysis under the direction of the Supervisor and Technical Operations.
  • Document test results, problems, and other relevant information under cGMPs.
  • Perform simple procedure and worksheet revisions, as necessary.
  • Participate in departmental meetings.
  • Maintain laboratory space and participate in lab clean ups.
  • Perform other responsibilities to support the needs of the department, as assigned by Supervisor.
  • Keep department lead or supervisors updated on all issues.

How will you get here?

  • Minimum BS/BA in Chemistry, Biochemistry, or Bioscience with 0-2 yrs. Quality Assurance/Quality Control experience, preferably in the medical diagnostics industry.
  • 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 and verbal communication skills.
  • Ability to follow written and verbal directions with a high level of accuracy.
  • Must be able to write clear, understandable documentation.
  • Manual dexterity must be able to lift/move up to 20 pounds.
  • Must be detail oriented and perform the work at a consistent level.
  • Intermediate word processing and spreadsheet software skills.
  • Strong organizational skills to be able to manage priorities and multiple tasks simultaneously.
  • Ability to perform simple data analysis and to summarize results. Basic math skills including calculation of concentrations and dilutions and a strong grasp of algebraic concepts.
  • Working knowledge of clinical analyzers is a plus.

 

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