Quality Control Manager
4 weeks ago
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Lilly employees embrace Operational Excellence in everything we do, to achieve our mission of Making Medicine with Safety First & Quality Always; following our common purpose under TEAM Lilly and our Manufacturing Standards under the strict code of conduct guided by our Red Book assuring data integrity in all we do in order to deliver a reliable supply of medicine for people around the world.
Position Brand Description:
Manages the day-to-day activities of up to 10 analytical staff. Plans work for the group to respond to changing priorities. Maintains a safe, orderly, and compliant work area according to company safety standards and cGMP regulations. Position requires 5 or more years of solid technical skills related to applied area. Assists with workload, as needed.
Key Objectives/Deliverables:
Manage for Results /Strategic Planning:
Manage the day-to-day activities of the assigned laboratory group:
Assign and monitor laboratory workload of routine and non-routine analyses by appropriate chemical, and biochemical, test methods. Reviews assays as needed. Plan and organize analytical projects required to achieve group and corporate objectives.Evaluate, coach, and manage personnel performance. Set group objectives with management.Build a strong, responsive team that is reliable, responsive, and flexible to shifting demands.Work independently but ensure communication of critical information upward with buy-in from senior management for key decision-making.Take initiative to make things better for the company, be aggressive with your work and assertive in your interactions, lead by example and build collaborative relationships. Be a technical resource for QC: Serve as a technical expert on the methods performed in the group and the results obtained.Use scientific expertise to provide assistance to coworkers for troubleshooting, laboratory investigations and problem resolution. Implement process improvements with management.Ensure QC Compliance: Assure adherence of acceptable cGMP practices by staff during execution of all work tasks. Compile and analyze/review data, prepare graphs, and write SOPs/reports. Conduct document reviews. Review test results for conformance with specifications and effective documents. Evaluate data to detect product or method-related trends. Write periodic trend summaries. Author investigations, changes, CAPAs, etc.Basic Requirements: BS or MS in a related science field such as a Biology or Biochemistry is required.Requires 5+ years of technical experience in protein product, preferably with 1+ year(s) supervisory experience. Excellent working knowledge of cGMP regulations for QC laboratory applications is required.Additional Preferences:Experience in monoclonal antibody is not required but a definite asset.Excellent teamwork and communication skills. Attentive to detail.Ability to take initiative, to be assertive, to lead by example and to build relationships. Superior writing skills and ability to communicate complex scientific information to audiences of various backgrounds. Demonstrated understanding and expertise in computer system applications, software, and data management (LIMS).Other Information: Travel not required. Lifting not required. Not required to be on call. Shift work may apply. Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups. #WeAreLilly
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