Genomic Health is seeking an outstanding individual to join our growing reagent manufacturing team. The primary responsibility of this position is to conduct daily operation of reagent manufacturing supporting our CLIA lab and new IVD products. Duties include executing reagent manufacturing operations according to defined procedures under GLP and GMP environment and ensuring the integrity and quality of products under ISO 13485:2016 requirements. The manufacturing associate will also support other laboratory activities such as calibration and maintenance of instrumentation. The Manufacturing Associate will also help alert deviations with reagents and consumables and participate in out of specification and failure investigations and implement corrective actions and process improvements. Additional opportunities include participating in cross functional teams with Process and Service Engineering, Supply Chain and Quality Assurance to conduct new or improved manufacturing process and instrument qualification studies.
The position will report to the Manufacturing Manager.
Responsibilities / Duties
Execute manufacturing SOP' to produce in house manufactured reagents under GLP and GMP environment
Document work according to SOP's and ISO 13485:2016 requirements
Perform manufacturing lab support activities such as instrumentation maintenance and calibration
Participate in cross functional teams to design, investigate or execute manufacturing processes
Document work according to SOPs and GHI quality requirements
B.S. Degree in biochemistry, analytical chemistry, chemical engineering or related discipline with 2 - 4 years of relevant experience in industry (Life Science GMP/IVD setting preferred)
ISO 13485 experience preferred
Relevant experience in a production environment including formulation work, using standard production control tools - ERP, LIMS, inventory control, and work orders
Ability to follow SOP's and work independently with minimal supervision
Familiarity with automated liquid handling systems such as Tecan or Hamilton is preferred.
Experience with lab equipment such as pipettes and balances. Nanodrop, centrifuges, pH and conductivity meter, density meter, HPLC, etc. a plus.
Ability to handle multiple tasks concurrently and in a timely fashion
Detail oriented, thorough and good communication skills with peers and cross functional groups
Proficiency in basic word processing and spreadsheet applications
Genomic Health, Inc.