Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale! Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer! We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

Our Greenville, NC site facility is a large, multipurpose pharmaceutical manufacturing and packaging campus./Drug Product Division (DPD)

How will you make an impact?

With a strong dedication to customer happiness, you’ll provide technical leadership and Quality oversight for our Solid Dose/Animal Health Manufacturing and Sterile Manufacturing Environments in association with specific aspects of Quality to ensure compliance with regulations that govern pharmaceuticals. You will responsible for driving strong Customer Happiness by ensuring compliance.

What will you do?

• Is responsible for product investigations, master batch records, protocols, product complaints and other quality related documentation as needed to support clinical and commercial products for the Solid Dose, Animal Health and Sterile operations.
• Provides oversight for 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 our system 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).
• Follows all job-related safety and other training requirements.

How will you get here?

Education

• Bachelor's Degree in a scientific or related field or an equivalent combination of education, training, and relevant work experience may be considered.

Experience

• A minimum of 5+ years of Quality Assurance or Operations experience in the pharmaceutical industry or a GMP environment.
• Experience in a Contract Development and Manufacturing Organization (CDMO) strongly preferred.

Knowledge, Skills and Abilities

• Makes good and timely decisions.
• Role models a continuous improvement mentality while meeting results.
• Consistently applies good judgment and maintains dedication to Thermo Fisher Scientific ethics and values.
• Promotes a customer-centered approach and is able to maintain an effective customer relationships.
• Strong leadership skills
• Self-starter, mature, independent and reliable. Ability to work in a high pressure fast-paced environment, able to multi-task and is results-oriented.
• Handles assigned asks with little oversight and takes initiative (i.e. problem solves unprompted).
• Outstanding attention to detail and organizational skills.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Accessibility/disability access

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