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Job Title:     Validation Analyst
Job Location:  CA: Thousand Oaks
Pay Rate:      $k - k
Job Length:    full time
Start Date:    2006-05-17

Company Name:  Kforce, Inc.
Contact:       Recruiter
Phone:         888-663-3626
Fax:           Click Apply On-Line

Description:   This position is required to lead the Change Control and validation activities of the current JD Edwards and future SAP ERP systems at our clients location. The job function requires strong leadership skills and working knowledge of FDA, 21 CFR Part 11, and SOX regulatory requirements as they pertain to IT systems in the Pharmaceutical/Biotech Industry. This position regularly interacts with various levels of client groups globally in regards to ERP system in the Finance, Sales and Distribution, Manufacturing, Logistics, Engineering, Quality; and will in the future with Research and Development areas too. The job function therefore requires strong written and verbal communication skills, as well as presentation skills. Responsibilities include being the primary ERP Change Manager contact for SOX Audits from Internal and external compliance audits. The role is expected to defend the ERP system during a regulatory inspection and provide coaching to ERP staff on how to address both internal and external audit questions and observations. Additional responsibilities include writing and updating ERP Operations SOPs, addressing IT Quality issues, understanding complex business processes that impact multiple functional areas, and providing impact statements on changes to the ERP System. The position is expected to demonstrate experience with technical documentation as it relates to the SDLC and computer validation.

Candidates must possess a Bachelors or Masters degree in Computer Science or a related field and 8 or more years of experience working with computer validation in regulated computer related systems. The selected Analyst should be able to demonstrate technical skills to include data analysis, business analysis, quality assessment, computer compliance, validation, and auditing. Candidates should be familiar with computer systems compliance and validation in an FDA /SEC regulated environment, software quality assurance, and change management. Familiarity with audit processes and security audits of systems is desirable. Additionally, knowledge or work experience in other regulations like SOX, DOORS, HIPPA, etc. is preferred. This position requires knowledge and experience EPIC software development methodologies. Knowledge of Change Control is also required.

Please send to attention of Recruiter.
Job Type: BioTech
This is a Full Time Position.


Please refer to Job code SCSQG628403 when responding to this ad.


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