QA SPECIALIST- DOCUMENTSShift: Monday-Friday 7:30-4:00pmProject Description:
NEW BRUNSWICK, NJ
- 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.
- 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: email@example.com
ALPHA'S REQUIREMENT #19-00828
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE