Thermo Fisher Scientific Sr. Quality Associate in Greenville, North Carolina
When you are part of the team at Thermo Fisher Scientific, you will do important work, and you will be valued and recognized for your performance. With talented managers and inspiring coworkers to support you, you will find the resources and opportunities to make significant contributions to the world.
The primary purpose of this position is to provide technical leadership and Quality oversight in association with specific aspects of Quality to ensure compliance with regulations that govern pharmaceuticals. Full compliance ensures the Company can operate without regulatory actions that impede product quality, cause product stoppages or reduce customer satisfaction.
Comply with all job-related safety and other training requirements. It is the responsibility of each employee to work in a safe and responsible manner in order to create an injury-free and incident-free workplace.
For processes and projects of moderate complexity, perform compliance assessments, make decisions regarding regulatory requirements, write new procedures and ensure adherence to current regulations.
Ensure 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.
Conduct 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.
Act as a technical resource for support of systems and new product introduction by proactively interpreting regulatory and compliance requirements, establishing and maintaining systems.
Perform QA batch disposition (release) decisions.
Authorities: Can be called upon to present in customer audits and as SME in regulatory audits regarding questions of moderate complexity.
Approves procedures and Quality Assurance records such as deviations, CAPA, audit actions.
Works on issues of moderate complexity in regards to compliance of processes and product within facilities, equipment, manufacturing and support areas.
Makes decisions while taking into account level of risks using written guidance in regards to compliance and product quality.
BS/BA in a scientific or related field plus 4 years experience in the pharmaceutical industry. OR AA/AS plus 5 years relevant experience.
Leadership roles of high level projects.
At Thermo Fisher Scientific, each one of our 65,000 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 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.