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Group Leader, Lab Services

Company: Thermo Fisher Scientific
Location: Greenville
Posted on: May 19, 2019

Job Description:

Job Description
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.

How you will make an impact

To provide laboratory testing support to meet the business objectives of Patheon, division of ThermoFisher.
What you will do
1. Manages staff responsible for the day-to-day operations of multiple quality operations. Review departures from procedures and recommend action for approval by Sr. Group Leader/Manager/Director. Approve GMP records.
2. 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.
3. 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.
4. 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.
5. Draft submission ready sections of regulatory dossiers for drug products for approval by management. Draft specification rationales for drug products. Draft standard operating procedures. Write appropriate reports and correspondence. As needed, write reports for clients.
6. 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.
7. 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.
8. Comply with all job-related safety and other training requirements.
9. Perform other duties as assigned.
How you will get here

Education and Experience

  • BS/BA in Microbiology or related discipline with four (4) years relevant experience to include two years leadership experience; Knowledge, Skills, and Abilities
    • Knowledge of quality control statistics, documentation and adherence to SOP s.
    • Adaptable to changing production schedule support, flexible and structured communication skills.
    • Knowledge of pharmaceutical water systems and Microbial test methods a plus.
    • Ability to write quality technical reports and give effective oral presentations. 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.

      Apply today!

      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.

      If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.
      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.

      Associated topics: antibody, aseptic technique, cytometry, dietary, disease, drug, food, histology, metabolism, virus

Keywords: Thermo Fisher Scientific, Greenville , Group Leader, Lab Services, Healthcare , Greenville, North Carolina

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