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Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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.

Excellent Benefits Package

Review our company’s Total Rewards (https://jobs.thermofisher.com/global/en/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

How will you make an impact?

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.

Essential Duties and Responsibilities:

+ Ensuring system compliance with applicable regulations throughout the software life cycle of development, implementation and maintenance of automated systemsinvovled in the t cGxP processes. In addition, supporting IT system initiatives to provide defensible data integrity across GxP systems.

+ Support 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.

+ Provide guidance related to data integrity initiatives/requirements for IT systems.

+ Partner with IT team members for global GxP systems.

+ Support 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

+ Provide expertise on Part 11 and Annex 11 forms and reports, including review/approval of regulatory impact system classification records.

+ Work with CSV to provide timely periodic system reviews and audit trail reports.

+ Attend project meetings to provide compliance direction and instructions to project team.

+ Assist with keeping System Inventory List up to date and accurate.

+ Create and provide 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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.