Posted 3 months ago
Documentation Specialist II
AI Summary
Documentation Specialist II tracks change control documentation and edits quality documents (SOPs, guidelines, validation master plans) to ensure regulatory compliance.
About this role
Documentation Specialist II
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.
Tracking and reviewing change control documentation.
Assist with the editing of quality documents (SOP's, guidelines, validation master plans, etc.) to ensure compliance with regulator requirements.
Must be able to work quickly with a high degree of accuracy.
Must possess sound interpersonal and information gathering skills, being able to relate well to others at all levels throughout the organization and have the ability to work in a team environment, effectively interacting with others.
Experience:
3 to 6 years.
Skills:
Must be proficient in Microsoft Office applications/ word processing skills, Adobe Acrobat, formatting.
Demonstrate SME level understanding of functional area electronic business systems and adaptability to learn new systems/processes.
Critical thinking skills are a must in order to develop strategies and/or enhance business practices and desired outcomes.
Peer to peer and upward communication professional business communication skills required.
Qualifications
Bachelor s degree preferred, but not required.
cGMP Training a Plus
Additional Information
Thanks & Regards,
Akriti Gupta
Associate Recruiter (Clinical / Scientific)
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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Skills
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