Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

The consultant will use his/her knowledge of FDA cGMP and related regulations and guidelines, and specific knowledge of computer system validation (CSV) methodologies and principles to perform CSV on a variety of laboratory systems in the QC department at the Canton site .

The successful candidate must be an independent performer with significant experience in a cGMP environment, and will work with minimal supervision.

Skills:

At least 2-4 years of Computer System Validation experience in a laboratory environment. Past experience writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ, PQ, DSN, summary report).

An excellent understanding of CFR-Part 11 Compliance for Electronic Data Systems.

A good understanding of laboratory instruments such as HPLC's, TOC, UV-Spectrophotometers , FT-IR's among others.

A good understanding of the Windows OS (XP/Windows7) including file hierarchies, Data Structures, Networking and VBS or other basic scripting languages. A basic understanding of Microsoft SQL is a plus.

BS in Chemistry/Biology/Computer Science or a related area with significant experience in laboratory instrumentation in a cGMP environment.

Best Regards,

Akriti Gupta

Associate Recruiter(Scientific & Clinical Division)

Artech Information Systems LLC

360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 

Office: 973.967.3409 | Fax: 973.998.2599

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