- 187858 - Engineer Scientist I
- CA-Bay Area
- 6 Months
- Chipton-Ross is seeking an Engineer Scientist I for an opening in Fremont, CA.
Using standard operating procedures (SOP) and good manufacturing practices (GMP), the Engineer/Scientist I will perform Release and Surveillance testing of 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.
Conducts analytical and functional testing of finished good kits and/or filled bottle reagents/calibrators according to approved SOPs as part of QC Release and Surveillance testing.
Perform testing using chemistry clinical analyzers and document test results accurately using Excel spreadsheets and workbooks.
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 by Supervisor.
Participate in PPI, Lean, and 5S programs, as required.
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 skills.
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 pounds.
Intermediate word processing and spreadsheet software skills.
Ability to manage multiple tasks simultaneously.
Ability to work independently.
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.
Accredited 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.
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x307 or (800) 927-9318 x307
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.