- Title: Change Control Associate
- Code: RCI-BMS-27867-1
- Location: Pennington New Jersey (NJ) 08534
- Posted Date: 07/09/2019
- Duration: 6 Months
- Status: Open
Talk to our Recruiter
- Name:Vishal Trivedi
- Email: email@example.com
- Phone: 908-704-8843 ✖ 435
- Provide overall validation and documentation support for the GxP biologics laboratory areas of Biologics Development.
- Provide support and assistance with the change control program through equipment qualifications and SOP review for and laboratory systems.
Major Duties & Responsibilities:
- Perform review of SOPs pertaining to laboratory systems.
- Provide input on changes pertaining equipment, computer systems and support change control program.
- Perform the review and approval of relocation, commissioning, qualification and validation documents pertaining to equipment, and computer systems.
- Assist with the execution of periodic re-qualification of instruments and review associated documents and test scripts for PCs used in GxP areas.
- Participate in internal audits as needed.
- Facilitate process improvement activities.
- Knowledge of FDA, EU and ICH guidelines and cGMPs related to laboratory testing and product release.
- Experience in Change Control Management
- Understanding of Commissioning, Qualification, and Validation
- Minimum of a Bachelor’s degree
- GMP experience in a regulated industry
- Familiarity with analytical laboratory testing
- Experience in the review and approval of GMP documentation
- Microsoft Office Applications
- Electronic Document Management Systems (e.g., Document Control and Archiving (DCA) System)
- TrackWise Quality Management System