Title: : Engineer Scientist I / QC
Location: Fremont, CA 94538
Duration: 5 Months
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.