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Senior Quality Scientist - 18-00841
Ref No.: 18-00841
Location: Rockland, California
Position Type:Contract
Start Date / End Date: 04/30/2018 to 04/29/2019
Position Summary: 

The Stability Program Lead will be part of the Quality Control (QC) team. He/she will be responsible for setting up a new stability program for IVDs along with other products. 

Responsibilities: 
  • Work independently and cross functionally between departments to establish new stability program. 
  • Be able to plan, schedule, manage/coordinate, and drive the entire program. 
  • Set up tracking and trending metrics for testing data. 
  • Draft and prepare protocol and final reports using standards and guidance documents including ICH Guidance Documents. 
  • Identifies quality improvement in areas of responsibility.
  • Other such duties as determined by Manager. 
  • This person will report to the site Quality Manager. 
Requirements: 
  • BS or MS in Chemistry/Biochemistry, Biology or related field. 
  • 5 plus years of experience working in a regulated environment which will include some stability knowledge/experience. 
  • Must have excellent interpersonal skills, writing skills, and communication skills. 
  • Good computer skills, PC including MS Excel. 
  • Good organizational skills and attention to detail. 
  • Ability to work independently and manage multiple priorities. 
  • Experience working in ISO 13485 and/or FDA regulated environment. 
  • Knowledge and experience in IHC, ELISA and Bioburden preferred. 
  • Knowledge of SAP and/or SAP NEXT preferred.