Thermo Fisher Scientific Senior QA Engineer in Boston, Massachusetts
Senior QA Engineer
Work from home remote opportunity in Software Quality Assurance
When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.
Location/Division Specific Information
Philadelphia - Remote location. Analytical Instruments Group/Digital Science Business Unit
How will you make an impact?
As part of the Quality team you will work to assure the quality objectives and the business requirements are met, building them into processes, ensuring compliance and driving improvement activities.
What will you do?
Assume 'QA' role in SDLC projects with globally distributed teams
Assume 'QA' role in infrastructure validation process
Host regulatory body audits in person or remotely
Conduct internal audits on global processes
Manage postal audits for regulated customers
Manage actions from all audits through to implementation and closure.
Create (or review/update) QA specific processes.
Execute (or assist with) any other QA processes listed on QMS.
Assist other departments in ensuring QMS is up to date and relevant to the business needs.
Manage (or assist with) tooling required to host QMS.
How will you get here?
- Degree in computing, science, or related discipline desired, high school diploma/GED is minimum requirement
At least 5 years Quality Assurance experience in a pharmaceutical aware environment.
Experience of process design.
Experience of Quality Assurance in a SaaS environment.
Experience in conducting and participating in Audits.
CSV (Computer System Validation) experience a plus.
Knowledge, Skills, Abilities
Knowledge of GxP regulations, GAMP and 21 CFR Part 11.
Knowledge of data privacy, GDPR and ISO27001 or SOC 2.
Knowledge of ISO9001:2015.
Basic computing skills including Microsoft applications (Visio and MS SharePoint an advantage).
Excellent oral and written communication skills.
Ability to travel 20% to 25% and work independently or in a group setting
At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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