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.

Duties and responsibilities:

• Work with the Quality Team to ensure company goals and objectives, policies and procedures are in compliance with Quality Systems, cGDP and FDA regulations.
• Work directly with investigation teams on quality issues and TrackWise problem record closures.
• Participate in change control activities for documents and manufacturing processes.
• Manage problem requests, complaint records, and corrective and preventive actions.
• Manage customer complaints, including trending and problem solving.
• Perform training on Quality procedures.
• Support activities within the Quality Management System as required. Ensure quality systems SOPs are being followed and alert the Quality team if any discrepancies found to drive escalation and corrective actions as needed.
• Support new and transfer product to be aligned with distribution requirements.
• Write and revise Standards Operating Procedure for Distribution activities and develop training content.
• Perform daily Good Distribution Practices checks and enforcement.
• Perform inspection on Order fulfillment activities as required and ensure all packaging guidelines, as well as good practices for Cold Chain pack-out, are met.
• Demonstrate the ability to work with the following systems is required: Microsoft Excel/Word, SAP, E1, Agile, and TrackWise.
• May be required to work in a warehouse environment under various temperatures including room temperature (59–86 degrees F), cold-room (36-46 degrees F), and/or freezer-room (minus 4 – 23 degrees F).
• May be required to routinely push and pull and/or lift up to 40 lbs (20 kg).
• Demonstrate the ability to work effectively on multiple assignments concurrently and meet standard response times and deadlines.
• Demonstrate the ability to reprioritize work quickly to meet changing demands.
• Possess good organizational skills and demonstrate a strong ability to work well within a team setting as well as independently.

Preferred Qualifications:

• Experience in the quality system of the distribution-related field is a plus
• Strong understanding of SAP and E1 transactions (Quality and Inventory focused)
• Knowledge of the FDA 820 and ISO13485
• Ability to multitask and achieve deadlines in a fast-paced environment
• Strong communication skills, both verbal and written, organizational skills, both analytical and problem solving, and the ability to work with confidential documents

Minimum Qualifications:

• Degree in Engineering, Biology, Chemistry, Science, or related degree required
• Minimum of 2-4 years related experience
• Proven ability to follow policies and procedures, instructions, and to meet schedules consistently and independently

This position is not approved for relocation benefits.

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 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, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues 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 and Patheon. For more information, please visit www.thermofisher.com.

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