1. Performs testing for reagent and control manufacturing products
according to Work Instructions to ensure they meet quality control
specifications: reviews as needed.
2. Identifies non-conformance and notifies supervisor or designee.
3. Performs OOS investigations and participates in identifying the root
cause if applicable.
4. Works in the spirit of Continued Improvement; identifies opportunities
to improve processes, procedures, and efficiency; participates in
accomplishing the improvements as applicable.
5. Performs routine operation, maintenance, calibration, and
troubleshooting of basic lab instruments such as pH and conductivity
meters, osmometers, and hematology analyzers.
6. Collects laboratory instrument data and enters into Excel spreadsheet.
7. Performs daily routine monitoring of temperature and humidity.
8. Performs microbiological testing of the DI water system, reagents
manufactured, control subassemblies, and finished products to ensure
9. Conducts environmental monitoring of the clean room and micro
10. Receives samples and performs qualification of raw materials.
11. Performs basic assay related activities including racking, running,
prepopulating and making assay sheets.
12. Maintains workplace safety and environmental practices.
13. Proactively collaborates and supports the team, communicates
problems as they arise and participates in identifying solutions.
14. Engages in inter and intra-departmental activities
15. Performs other related duties as required or as directed. The omission of specific duties does not preclude the supervisor from assigning duties that are logically in relation to the position.
1. Ability to understand written or verbal instructions in English.
2. Must be able to follow protocols and methods.
3. Scientific capability to gather data and interpret results and make
judgement as applicable.
4. Must be able to review QC data, identify, and recommend potential
5. Must have the ability to read, understand, follow, and enforce safety
6. Capable in the use of the computer and working knowledge of Excel.
7. Basic knowledge of GMP, ISO, and GLP requirements.
8. Must be able to multitask and prioritize.
9. Must be self-driven and highly motivated.
10. The individual should be a team player.
11. The individual should be highly organized and adaptable.
1. Bachelor's degree in a scientific field, with one year of laboratory
experience or Associates degree with 3 years of laboratory experience.