Validation Specialist II

artechinformationsystemllc
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📍 Canton📍 Canton, MA, United States📍 MA📍 usContract

About this role

Company Description

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.

Job Description

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.


Qualifications

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

Additional Information

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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Frequently Asked Questions

Is the salary disclosed for the Validation Specialist II position at artechinformationsystemllc?
The salary for this Validation Specialist II role at artechinformationsystemllc is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Validation Specialist II position at artechinformationsystemllc located?
This Validation Specialist II role at artechinformationsystemllc is based in Canton, Canton, MA, United States, MA, us. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Validation Specialist II role at artechinformationsystemllc full-time or part-time?
This is listed as a Contract position. It is posted as a Validation Specialist II role at artechinformationsystemllc.
How do I apply for the Validation Specialist II position at artechinformationsystemllc?
Click the "Apply Now" button on this page. You will be redirected to artechinformationsystemllc's official application portal hosted on smartrecruiters where you can submit your application directly.
When was the Validation Specialist II job at artechinformationsystemllc posted?
This Validation Specialist II position at artechinformationsystemllc was posted on Feb 11, 2016. Apply as soon as possible — early applications are often reviewed first.
Validation Specialist II
artechinformationsystemllc
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