Senior Qualification & Data Integrity Specialist

New Brunswick, NJ

Posted: 07/14/2022 Job Number: 21116574

Job Description

SENIOR QUALIFICATION & DATA INTEGRITY SPECIALIST
NEW BRUNSWICK, NJ
1 or 2 days remote and 3-4 Onsite .

Project Description:
  • Preparation of data integrity risk assessments for computerized system in the laboratory.
  • This includes, but is not limited to, interacting with instrument vendor to understand data flow, application software features, data file generated and Part 11 compliance features on the application software.
  • Working closely with instrument owner to setup the system and complete data integrity risk assessment in assigned timelines .
  • Experience with instrument qualification, vendor protocol preapproval, periodic calibration, performance verification, preventive maintenance, change control, decommissioning, and documentation archival .
  • Collaborate with the quality unit to ensure completeness and accuracy of submitted documentation, as well as addressing/resolving compliance concerns to GMP regulatory standards .
  • Management of user accounts, password reset etc., as requested by users .
  • Verification of data backup and restore activities .
  • Participation in preparation of standard operating procedures .

Required Skills:
  • The qualified individual must have a Bachelor of Science in chemistry, biology, computer, or related science with 3-6 years of relevant laboratory experience .
  • Demonstrated understanding of compliance, cGMP and FDA requirements including Good Documentation Practices (GDP) as well as laboratory GMP principles (21CFR Part 210 / Part 211) .
  • Must be detailed oriented, well organized with excellent communication and technical writing skills .
  • Capable of working both independently as well as in the team, driving projects to completion with minimal oversight .
  • Must have customer focused attitude and able to meet the assigned timelines .
  • Must have ability to interact and accurately communicate the information with appropriate team members, co-workers, and supervisor .
  • Must be self-motivated and driven to move the project to completion .
  • Experience and understanding of 21 CFR Part 11 compliance for computer system (hardware, application software and operating system) .
  • Understanding of Data Integrity concepts in GxP work environment .
  • Experience with instrument/equipment qualification, deviation and change control process.
  • Ability to create documents using existing document templates .
  • Possess firm understanding of data file types generated by laboratory instruments including database structure .

This 12+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Angie: angie@alphaconsulting.Com

ALPHA'S REQUIREMENT #22-02136
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

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Angie Dawn

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