Using standard operating procedures (SOP) and good manufacturing practices (GMP), the Engineer/Scientist I will perform 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.
- Conducts analytical and functional testing of finished good kits and/or filled bottle reagents/calibrators according to approved SOPs as part of QC 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.
- 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 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.