Technician, Computer Lead

2 weeks ago

Concord CA, United States Lilly Full time

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 make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
The Lead Technician QA is responsible for providing QA oversight to GMP operations. The role will provide QA support of the start-up and qualification of the Concord site. The QA Floor Support Specialist will demonstrate teamwork by collaborating cross functionally with various levels of the organization. As the project progresses, this role will transition to supporting and escalating issues from manufacturing to the site-based process team for one of the following manufacturing areas:
Formulation and Equipment Preparation Processes
Automated and Semi-automated Visual Inspection
Support on-the-floor manufacturing activities with routine presence in the assigned manufacturing area.
Support creation of Standard Operating Procedures and associated Forms, Tools and Training.
Troubleshoot and provide support to resolve equipment alarms and other issues in quality systems such as Trackwise and MES.
Support the execution of inspection readiness activities including support of site self-inspections.
Support project initiatives needed for the project and Quality function.
Communicate any compliance issues associated with the project or site to Quality Management.
Evaluate potential product quality impact for any GMP-related incident and support the investigation and assist with safety investigations.

Knowledge of cGMP practices including good documentation practices, data integrity and regulatory compliance
Ability to work independently with minimal supervision
Proficiency with computer systems including Trackwise, MES, Microsoft Programs
Responsible for maintaining a safe work environment, working safely & accountable for supporting all HSE Corporate, Project, and Site Goals
H-1B or TN status) for employment positions on the B paths or at R1 Level.
Associates or Bachelors degree in a science, engineering, computer, or pharmaceutical related field of study, preferred
Previous experience with GMP manufacturing equipment prep, formulation, filling, and visual inspection
Previous technical writing experience
Ability to work 12 hour shifts onsite on a rotating 2-2-3 schedule (not eligible for remote work)
Overtime and off-shift support may be required
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. Please note This email address is intended for use only to request an accommodation as part of the application process. 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. 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.

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