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Quality Assurance Specialist

2 months ago


Bohemia, New York, United States Thermo Fisher Scientific Full time
Job Summary

Thermo Fisher Scientific is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our Clinical Supply Chain department, you will play a critical role in ensuring the highest level of quality, performance, reliability, and sustainability standards are met.

Key Responsibilities
  • Proactively identify and coordinate the reporting of Data Integrity issues and findings through Global TrackWise.
  • Coordinate actions for global harmonization of procedures across Clinical Labeling sites.
  • Support the harmonization of key processes across all Clinical Labeling Services locations.
  • Assist in supporting the management of Documentum (Electronic Document Management Systems, eDMS) for the site.
  • Monitor all Periodic Reviews from issuance to completion.
  • Handle the creation and release of site logbooks.
  • Provide Right First Time, monthly business review site metrics, and department metrics to the QS Manager and site QA Analyst.
  • Participate in Practical Process Improvement (PPI) teams.
Requirements
  • Minimum of 5 years of meaningful experience in the pharmaceutical industry or 3 years with an advanced degree.
  • Knowledge of cGMPs.
  • Outstanding problem-solving skills.
  • Attention to detail.
  • Ability to multi-task.
  • Excellent oral and written communications skills.
  • Ability to work with company/client confidential information.
What We Offer
  • A competitive hourly pay range of $25.00–$35.00.
  • A comprehensive Total Rewards package, including a choice of national medical and dental plans, employee assistance and family support programs, paid time off, and retirement and savings programs.

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.