Global Senior Quality Specialist - IT QA

Position Overview

As part of the Thermo Fisher Scientific team, you’ll 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 world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

At Thermo Fisher Scientific Inc., we are committed to innovation and excellence. As a Global Senior Quality Specialist on the IT QA team, you will play a pivotal role in ensuring our GxP computerized systems and IT processes/activities are compliant. Your work will contribute to a premier software lifecycle development approach, improving our Clinical Trial Divisions (CTD) GxP systems, including Data Integrity standards. This position will collaborate closely with IT personnel and other functions across the entire CTD network.

Employment Type

• Full-time

Work Schedule

• Standard (Mon-Fri)

Environmental Conditions

• Office

Responsibilities

• Ensuring system compliance with applicable regulations throughout the software life cycle of development, implementation and maintenance of automated systems involved in cGxP processes.
• Supporting IT system initiatives to provide defensible data integrity across GxP systems.
• Supporting all aspects of the company's Computer System Validation and global IT activities for the systems that support cGMP processes for the division.
• Quality review of Computer System Validation deliverables.
• Providing guidance related to data integrity initiatives/requirements for IT systems.
• Partnering with IT team members for global GxP systems.
• Supporting site & business unit IT compliance activities.
• Experience with quality records, such as change controls, deviations, and CAPAs.
• Hands-on experience with electronic quality systems such as TrackWise (QMS) and Documentum (EDMS).
• Supporting internal and client audits and/or regulatory inspections.
• Providing expertise on Part 11 and Annex 11 forms and reports, including review/approval of regulatory impact system classification records.
• Working with CSV to provide timely periodic system reviews and audit trail reports.
• Attending project meetings to provide compliance direction and instructions to project team.
• Assisting with keeping System Inventory List up to date and accurate.
• Creating and providing guidance on CSV and Quality Related SOPs and Work Instructions.

Education/Experience

• Bachelor's degree is preferred, but will consider relevant work experience and education.
• Minimum of 5 years’ experience in computer validation.

Benefits Package

Review our company’s Total Rewards:

• Medical, Dental, & Vision benefits - effective Day 1
• Paid Time Off & Holidays
• 401K Company Match up to 6%
• Tuition Reimbursement – eligible after 90 days!
• Employee Referral Bonus
• Employee Discount Program
• Recognition Program
• Charitable Gift Matching
• Company Paid Parental Leave
• Career Advancement Opportunities