Thermo Fisher Scientific Lead Quality Specialist in Greenville, North Carolina
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
Patheon, by Thermo Fisher Scientific, is transforming the way pharmaceuticals are made with a simplified, end-to-end supply chain for pharmaceutical and biopharmaceutical companies of all sizes. Drug substances and drug products. Development and manufacturing.
Our Greenville, NC site facility is a large, multipurpose pharmaceutical manufacturing and packaging campus. This site provides both solid dose form manufacturing/packaging and sterile dose manufacturing, filling and lyophilization of both biopharmaceuticals and small molecules.
How will you make an impact?
With a strong Customer Focus, you'll provide technical leadership and Quality oversight for a Sterile Manufacturing Environment in association with specific aspects of Quality to ensure compliance with regulations that govern pharmaceuticals. You'll be responsible for driving strong Customer Satisfaction by ensuring compliance.
What will you do?
Drives processes and projects of moderate complexity, perform compliance assessments, make decisions regarding regulatory requirements, write new procedures and ensure adherence to current regulations.
Ensures quality of methods, processes, materials and products by providing coordination and review of group operations, staff training, and the assessment/improvement of systems and processes.
Conducts risk assessments and take appropriate actions during quality system management and oversight activities (e.g. during review/approval) to ensure adequate controls in relation to the level of product quality, safety and business risks.
Acts as a technical resource for support of systems and new product introduction by proactively interpreting regulatory and compliance requirements, establishing and maintaining systems.
Performs QA batch disposition (release decisions).
How will you get here?
- Bachelor's Degree in a scientific or related field.
A minimum of 7 years of Quality Assurance or Operations experience in the pharmaceutical industry or a GMP environment.
Experience in a Steriles Manufacturing environment strongly preferred.
Knowledge, Skills and Abilities
Makes good and timely decisions.
Role models a continuous improvement mindset while meeting deliverables.
Consistently applies good judgment and maintains commitment to Thermo Fisher Scientific ethics and values.
Promotes a customer-centered approach and is able to maintain an effective customer relationships.
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.