Stability Testing Medical Devices
We are looking for someone experienced in Stability Testing. He/she will be part of the Quality Control (QC) team and will be responsible for setting up a new stability program for IVDs along with other products. This is a Contract (temp to hire) position.
- 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.
Working hours: 8:00 AM - 5:00 PM
--BS or MS in Chemistry/Biochemistry, Biology or related field.
-- 5 plus years of experience working in a regulated environment which will include 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.
Interested? Please send updated resume to Rebecca.Ricksgers@external.emdmillipore.com or call my desk line at 951-514-4501!
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