Computer Systems Validation Analyst - (US-NJ-Mahwah)

Computer Systems Validation Analyst - (US-NJ-Mahwah)

Compensation: $65K - $90K / Year
Minimum Education: Bachelors
Job Type: Full Time
Jobcode: SBRJA1
PAID RELOCATION AVAILABLE

If not you, would you know someone???  I will pay a finders' fee if you refer someone who is hired.

Experience Required : 3 - 5 years
Degree Required : 4 Year Degree
Travel Required : to 25%

Bachelor's Degree in a scientific field of study plus 2+ years experience in a scientific discipline OR Master's Degree in a technical/scientific field of study. Prefer professional certification and/or formal training in IT Compliance, FDA Validation, 21 CFR Part 11. Prefer certificate and/or formal training in Project Management.

JOB DESCRIPTION:
Leverage experience / expertise in project management, systems quality & compliance, and change management to assist and the Information Technology organization in achieving and maintaining ongoing compliance with 21 CFR Part 820, Quality System Regulation, 21 CFR Part 11, Electronic Records; Electronic Signatures and Sarbanes Oxley Regulation.

Qualifications/Work Experience:
Assist in the establishment, execution, and maintenance of the IT Compliance program.
Oversee and manage IT Controls and Compliance administration (Change Control, Incident Reporting, IT Docs).
Oversee and manage the Global program of 21 CFR Part 11 Systems Assessment and Remediation; includes Electronic Signature Management, and coordination / establishment of Divisional Policies and Procedures.
Lead and manage strategic projects that contribute to the improved state of systems compliance and systems validation; includes design and development of control processes, documentation, training and maintenance.
Assist in development of validation/systems compliance training on systems compliance initiatives; provide continuing compliance education support to the Global IT Organization.
Develop, execute and manage computer validation activities in accordance with company policies, standards and regulatory expectations; includes preparation and review of validation and qualification protocols, analysis of data, and preparation and review of validation and qualification summary reports.
Perform vendor audits of software suppliers.
Assist in establishment of internal company documentation (SOPs).
Support internal IT Change Control procedures; provide quality systems review of applicable changes.

Percent Travel Required 25%

Candidate Must Have :
* Experience in Computer Systems Validation; not just validation

Email resume in Word to TheBigGameHunter@cisny.com. Please include the job code for the position with your resume.

NO VISA TRANSFERS. NO OVERSEAS RESUMES. NO 3RD PARTIES.

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Jeff Altman, The Big Game Hunter
Concepts In Staffing
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New York, NY 10016