Previous Job
Previous
Instrument Compliance Specialist / QC Associate
Ref No.: 18-00379
Location: New Brunswick, New Jersey
Position Type:Contract
Start Date: 03/21/2018
INSTRUMENT COMPLIANCE SPECIALIST / QC ASSOCIATE
NEW BRUNSWICK, NJ

Project Description:
  • Responsible for assisting analytical instrument owners, to navigate through the requirements of the GMP instrument program from qualification to decommissioning. This includes, but is not limited to qualification, vendor protocol preapproval, periodic calibration, performance verification, preventive maintenance, change control, decommissioning and documentation archival.
  • Responsibilities include collaboration with the quality unit to insure completeness and accuracy of submitted documentation, as well as addressing/resolving compliance concerns to GMP regulatory standards.
  • Collaborating with external contract service providers to ensure the requirements of the GMP instrument program are met.
  • Provide support to the Analytical Strategy & Operations (ASO) management team in internal and external audit inspections.
  • Responsible for continuing to drive the transition from instrument paper logbooks to an electronic instrument logbook.

Required Skills:
  • The qualified individual must have a Bachelor of Science or related field.
  • 2-5 years of experience preferred within a regulated GMP environment, but not required.
  • Experience using instrumentation for various analytical techniques with a focus on qualification.
  • Candidate must be detail oriented, well organized, and an excellent communicator with exceptional technical writing skills.
  • Capable of working both independently as well as with the team driving projects to completion with minimal oversight.
  • Knowledge of laboratory GMP principles (21CFR Part 210/Part211) and Good Documentation Practices (GDP) is required.

This 6+ month position starts ASAP.

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

ALPHA'S REQUIREMENT #18-00379
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE