QA Specialist- Documents

Posted On Sep 10, 2019 Location ,New Jersey
Experience 3 yrs- 5 yrs Duration Contract

Description

Job Description

QA SPECIALIST- DOCUMENTS
NEW BRUNSWICK, NJ


Shift: Monday-Friday 7:30-4:00pm

Project Description:
  • Provide support on the implementation and maintenance of the document control and training program as well as other Quality Systems.
  • Ensure compliance by following Client records management and retention policies and providing audit support.
  • Accountable for metrics generation and communication.
  • Support Client electronic records/document management system.
  • Support Client records retention policy.
  • Support Enterprise Systems such as QUMAS (PDHQ, DocMan) either functioning as an Administrator or Content Manager.
  • Data entry into various electronic records management systems.
  • Track, trend and report quality metrics to senior management through Key Performance Indicators (KPIs).
  • Support and participate in audits of Product Development Operations.
  • Adherence to Client core behaviors.

Required Skills:
  • Knowledge of science generally attained through studies resulting in a B.S., in chemistry, pharmacy or biology or a related pharmaceutical science.
  • Minimum of 3-5 years' experience in pharmaceutical quality.
  • Knowledge of QUMAS and other Enterprise Systems is highly desirable.
  • Proficiency with MS Office Suite.
  • Demonstrated proficiency in interpretation of FDA and EMA cGMP regulations as they apply to clinical supplies.
  • Experience in R& D environment is highly desirable.
  • Demonstrated interpersonal, communication, and motivation skills.

This 6+ month position starts ASAP.

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

ALPHA'S REQUIREMENT #19-00828
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

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