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Quality Compliance Associate
Ref No.: 18-00660
Location: Branchburg, New Jersey
Position Type:Contract
Start Date / End Date: 06/11/2018 to 12/28/2018
QUALITY COMPLIANCE ASSOCIATE
BRANCHBURG, NJ

Project Description:
Under management supervision, the Quality Compliance Associate Analyst will support all aspects of the Quality Compliance processes, including monitoring of applicable standards/regulations and facilitating the assessment of standards/regulations for changes impacting the business; monitoring internal audit records to ensure timely closure, supporting external inspection activities as needed and maintaining compliance files and tracking databases.
  • Support the control of external standards/regulations process by:
    • Monitoring external standards/regulations applicable to the business.
    • Facilitating the assessment of standards/regulations for changes impacting Client.
    • Facilitating the review and approval of standards/regulations gap assessment forms.
    • Ensuring remediation of gaps identified during the assessment is completed.
  • Monitor the Internal Audit TrackWise system to ensure that internal audit records, including observation, response and action records are assigned and completed timely.
  • Support the management of external inspections by ensuring adequate resources (e.g. meeting rooms, general logistics, equipment, personnel) are available for inspections and performing any inspection readiness activities as required.
  • Maintain compliance files and tracking databases.


Required Skills:
  • BA/BS in Technical Field is required.
  • Excellent technical writing and verbal communication skills.
  • Experience with MS Office applications including Word, Excel, PowerPoint presentation & Outlook.
  • Knowledge of relevant regulations/standards, i.e., ISO13485, FDA 21CFR820, FDA 21CFR1271, AATB, etc.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Steven: steven@alphaconsulting.com

ALPHA'S REQUIREMENT #18-00660
W2 ONLY MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE