Thermo Fisher Scientific Group Leader, Lab Services in Greenville, North Carolina
When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
Manages staff responsible for the day-to-day operations of multiple quality operations including In process product Chemistry testing, Microbiological testing, and Water testing . Review departures from procedures and recommend action for approval by Sr. Group Leader/Manager/Director. Approve GMP records.
Monitor the performance of staff such that corporate and business goals are met. Meet throughput goals for batch dispositions, assessment, investigations, and validation projects. Recruit and develop staff. Train staff. Apply progressive discipline programs as required.
Develop and implement policies and procedures. Implement approved changes in collaboration with labs, production, regulatory, client and Quality. Ensure that work is appropriately documented per GMP. Make decisions regarding acceptability of results and documentation. Identify issues requiring review by management.
Establish actions and implement systems to achieve process improvements and efficiencies to address shortcomings in processes and systems. Serve as principle in problem solving, failure analysis and quality or process system design activities related to product quality. Evaluate protocols, procedures, documents and results for scientific and/or business merit. Ensure areas of responsibility are compliant with industry standards and trends.
Draft standard operating procedures. Write appropriate reports and correspondence. As needed, write reports for clients.
Maintain knowledge of public standards, regulatory trends and cGMPs. Serve as the technical and regulatory expert in their operational area. Back up to key regulatory inspection contact. Participate in negotiations with clients, regulatory reviewers and inspectors on issues to assure timely resolution of issues or approval of client applications.
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.
Comply with all job-related safety and other training requirements.
Perform other duties as assigned.
BS/BA in a scientific or related discipline with four (4) years relevant experience to include two years leadership experience; OR
AA/AS degree in a scientific or related discipline with five (5) years relevant experience, including two years leadership; OR
Six (6) years relevant laboratory experience with two years leadership experience.
Knowledge of methods development approaches, analytical validations, quality control statistics, documentation and adherence to SOP’s.
Ability to write quality technical reports and give effective oral presentations.
Ability to effectively collaborate with others to achieve team goals and expectations.
Communicates effectively and in a timely manner in support of production activities.
A genuine interest in researching and implementation of new approaches to analysis
At Thermo Fisher Scientific, each one of our 70,000 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.