How Will You Make an Impact?
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
What will you do?
Review and approves validation protocols for product and process changes
Review and approve revision changes to DOPs, manufacturing process, components, software and labeling
Ensure failure investigations are performed and well documented for non-conforming materials and products
Establish and maintain database to track root cause, disposition, and cost for non-conforming material
Review customer complaints and analyze data for trends
Identify quality issues through data and trend analysis, work with relevant functions on corrective and preventive actions
Work with management to devise and implement quality strategies and policies
How will you get here?
Qualifications:
Degree in Science, Engineering or equivalent
Experience:
Minimum 2 years QA experience, preferably in pharmaceutical / biotech industries
Working knowledge of ISO 13485 and QSR preferred
Knowledge, Skills, Abilities
Excellent verbal and written communication skills
Proficient in the use of quality tools (eg. Trend, regression charts) to present and articulate identified issues
Self-motivated, results oriented with strong planning and scheduling skills
Applies knowledge to principles and concepts which contributes to the development and enhancement of company processes
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