Job Description

* Job Title: Lead Packaging/Labeling Technician
Requisition ID: 144719BR
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: Greenville, NC

How will you make an impact?
Provide guidance for review specialists in compliance requirements, coordinate and prioritize batch record review to meet shipment times along with developing training content for operations to understand ALCOA and Good Documentation Practices. Typical shift is 12-hour nights on a 3-2-2 rotation; 7:00p-7:00a.

What will you do?

* Manage SAP escalations and qualifications
* Provide oversight and participate in Data Integrity audits
* Serve as a support function during regulatory audits
* Provide guidance to supervisors in regard to documentation compliance in official documentation
* Serve as a liaison between QA Release and Operations
* Review Production Batch Records for compliance to procedures and regulatory requirements
* Review SAP transactions for each batch
* Analyze trends in production documentation (documentation errors, cycle times, financial metrics, etc.)
* Lead improvement events in regard to documentation
* Lead and facilitate root cause investigations
* Author protocols and deviation investigations
* Remain current with the understanding of regulatory requirements and provides leadership to identify and resolve gaps.

* How will you get here?
Education:
High School diploma or equivalent required. Some college preferred.
Experience:
At least 3 years of manufacturing or pharmaceutical experience and 1 year in a leadership role is preferred.

Equivalency:
With an associate degree, at least 2 years of manufacturing or pharmaceutical experience and 1 year in a leadership role will be considered.

Knowledge, Skills, Abilities:

* Troubleshooting/problem solving complex problems and risk analysis.
* Knowledge of Current Good Manufacturing Practices (cGMP).
* Management and delegation.
* 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.
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.