Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.
DESCRIPTION:
At Thermo Fisher Scientific youll join a quality assurance team focused on ensuring consistent execution of quality standards and regulatory compliance. Youll play a vital role in enabling our customers to make breakthrough discoveries and innovations that make the world healthier cleaner and safer. Youll ensure product quality drive continuous improvement initiatives and collaborate with cross-functional teams to maintain the highest standards of quality and compliance in a GMP environment.
REQUIREMENTS:
Bachelors Degree required no prior experience required. Experience in pharmaceutical medical device or regulated industry preferred
Preferred Fields of Study: Chemistry Biology Biotechnology Engineering or related scientific/technical field
Knowledge in computerized systems installed in the Manufacturing and QC Department - CSV
Knowledge of Empower (preferred)
Ability to work independently and collaborate effectively with cross-functional teams
JOB DESCRIPTION
Manage user permission/profile not managed by IT for CFR 21 part 11 systems and password recipes and other parameters for not CFR 21 part 11 instrument like balances pH-meters;
User Management
Execute back up of relevant data in case of manual processes;
Support Automation and Maintenance Team for troubleshooting
Support departments during system SOP drafting; follow the equipment/computer system validation activities;
Support the Team Write specific procedures an maintain their own managed computer system list according to SOP for SOD;
Complete the DI risk assessment for new systems
If needed meet with vendors to discuss software capabilities in regards to 21CFR Part 11 compliance;
Collaborate on projects to meet vendor business and regulatory requirements.
Required Experience:
Unclear Seniority
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more