Validation QA Reviewer/Advisor  

VALIDATION QA REVIEWER

COMPANY INFO:
MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries. We specialize in the nationwide recruitment of clinical trials personnel.

Our client is a global, broad-based health care company devoted to discovering new medicines, new technologies and new ways to manage health and is seeking to add a Validation QA Reviewer/Advisor to their team in Santa Clara, California.

RESPONSIBILITIES:
•    Will be reviewing and approving a large amount of protocols and reports as part of a special validation program effort.
•    Will work with cross functional team to design strategy for each validation.
•    May have other responsibilities in advising on software validation process and strategy per SOPs.
•    May also review on-going daily validation protocols and reports outside the scope of the special validation program effort.

•    Writing validation protocols and execution in a medical device/IVDD environment
•    QA review of validation packages
•    Experience reviewing both reagent and instrument manufacturing packages
•    Working on validation cross-function teams as QA representative
•    Experience in Analytical Method Validation and cleaning validation a plus.
•    Compliance knowledge of FDA and ISO requirements.
•    GHTF S3 Validation Guidelines a plus.

MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.

MedFocus is a respected provider of clinical personnel to the leading pharmaceutical and biotech companies across the U.S. We provide competitive salary and benefit packages along with the chance to work with the most sought after companies in the industry.

MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries. We specialize in the nationwide recruitment of clinical trials personnel.

MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.