Manufacturing Technical Support
Performs a variety of tasks associated with the investigation and troubleshooting of products, material and component qualification, improvement of existing products under the supervision and guidance by senior scientists. Supports the investigation into and implementation of product and manufacturing process changes, and the transfer of new products and processes to the manufacturing departments.
Manage data associated with projects, including generation of graphs and tables. Familiarity with flow cytometer and Sysmex hematology analyzers.
Work hours: Regular office hours with some flexibility
ESSENTIAL DUTIES AND RESPONSIBILITIES
1. Perform experimental studies utilizing the company's diagnostic platforms (automated instruments) as directed by senior scientists, approved protocols, written instructions in support of material qualification studies, product investigation studies, or product development/improvement studies.
2. Perform accurate and timely documentation, per GDP, all aspects of the study, inclusive of test results, observations, etc. as defined per written procedure or protocol.
3. Maintain data in a well organized, easy to locate fashion during all aspects of the studies.
4. Assist senior scientists with data tabulation & entry into excel spreadsheets, minitab worksheets, etc.
5. Perform routine maintanance of instrument platforms
6. Perform biological sample preparation from human blood and blood products.
7. Maintain accurate inventory of test samples, test reagents, supplies, etc. and procure additional materials through approved processes, inclusive of coordination and delivery from other departments.
8. Establish and maintain accurate identification/labeling of all test samples.
9. Organize and maintain the proper storage of all test samples and materials.
10. Centralize ordering and delivery of reagents
11. Maintain biohazardous waste containers
12. Ensure lab and all workstations are properly supplied, clean and well organized prior to study execution.
13. Support any administrative functions to ensure the appropriate day to day departmental operations.
14. Participate in developing departmental procedures, quality plans/device master records, and/or work instructions.
15. Participates in departmental internal audit process
16. Performs assigned training in a timely fashion as directed by L&D learning tracks.
17.Follows applicable laboratory OSHA regulations with respect to chemical hazards, blood-borne pathogens, safety, etc. (responsibility 100% of time).
18. Understands ANSI/ISO/ASQC Q9001, 21 CFR 1 99, 200's, 800's ,600's and EN46001 standards as applied to corporate quality system.
19. Understands source, composition, and characteristics of products and associated chemical and biosafety hazards.
20. Interacts cooperatively with coworkers, managers, and employees of other departments. Receives direction well from superiors.
Must be available to work irregular hours as necessary in the development, verification, or validation of products or processes or to meet project schedules. Work shift may vary according to department project.
Min - BS degree
Should have experience in Clinical Lab, blood bank or hematology. Reference Lab or Hospital Lab
Certification- MT or Blood bank helpful but not needed