Experience Required
60 MONTHS
Minimum Education Required
BACHELOR'S DEGREE
Compensation
$124,176.00 - $124,176.00 / Yearly
Hours Per Week
40
Number Of Positions
5
Shift
First Shift (Day)
Job Description
Gather and analyze information for product codes, device description, FDA listing numbers and GMDN codes. Design, develop, test, document & support of cGxP systems asper 21CFR Part11 & US FDA. Responsible for qualification & validation (IQ/OQ/PQ), master plans, protocols, changes requests, gap & root cause analysis, risk management plans, traceability matrix, summary reports for facilities, equipment, systems & processes. Prepare, review, authorize & submission of documentation for quality compliance & regulatory authorities. Bachelor’s degree in Science, Technology, Engineering, Chemistry, Pharmacy, Biology, Health Science, or Regulatory Affairs (any) along with five (05) years of experience in the job offered or related occupation is required. Work location: Iselin, NJ and various unanticipated locations throughout the U.S.
Email Resume to HR Dept., Intellectt, Inc., at hr@intellectt.com
Place of Work
On-site
Requisition ID
RAS_471
Job Type
Full Time
Application Email
hr@intellectt.com