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Executive Order 11246, Section 503 & VEVRAA EOE, including disability/vets
LIMS Validation Research System Design Protocols Clinical Experience Analyst
(Jobs
 
Requirement id 14836
Job title Analyst
Job location in S VIENTOS RANCH, CA
Skills required LIMS, Validation, Research, System Design Protocols Clinical Experie
Open Date 29-Jul-2013
Close Date
Job type Contract
Duration 3 Months
Compensation DOE
Status requirement ---
Job interview type Face to Face interview
Apply
   Email Recruiter: coolsoft
Job Description Analyst: LIMS, Validation, Research, System Design Protocols Clinical Experie

Senior Validation Analyst - Thousand Oaks, California

Primarily responsible for ensuring adherence to computer validation standards and procedures for computer related systems. Responsibilities include participation in system design, preparation of test protocols, analysis of test results and preparation of summaries. Provides guidance and sets standards in producing quality documentation, serves as the liaison between the IS and Quality functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in the resolution of IT Quality/Project compliance issues.


Strong experience with computer systems validation at Amgen for GLP/GCP regulated systems such as Laboratory Information Management Systems (LIMS) supporting preclinical and clinical development, in the Translational Sciences area for a biotech or pharmaceutical company.

Science background (e.g., bachelors in science) as well as software technical and computer systems validation, albeit focus will be on validating scientific applications linked to LIMS with a focus on preclinical and clinical study data definitions and data integrity.
Very strong analytical and communication (verbal and writing) skills and able to work independently and efficiently.

Our area is more research oriented (i.e., clinical study data analysis), rather than clinical data management. So the ability to identify and diagnose application software problems, particularly as it relates to data integrity, is key.

Nice-to-haves:

Experience with instrument validation.
Experience with Pharma specific validation processes and using HP Quality Center.

Preferred:
Masters degree - Science
 
Call 502-379-4456 Ext 100 for more details. Please provide Requirement id: 14836 while calling.
 
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(Analyst: LIMS, Validation, Research, System Design Protocols Clinical Experie in S VIENTOS RANCH, CA)
     
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