Lead Technician- QA PAR; Day Shift

Overview

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.

At Lilly, we serve an extraordinary purpose. 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 Quality Assurance Floor Support Specialist 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
• Parenteral Filling (Pre-Filled Syringes)
• Automated and Semi-automated Visual Inspection

• Support on-the-floor manufacturing activities with routine presence in the assigned manufacturing area.
• Follow good documentation practices and compliance with site procedures.
• Review and approve GMP documentation such as electronic batch records, logbooks, etc.
• 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 Veeva and MES.
• Maintain open communications between cross functional teams and area leadership.
• 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.

• High School diploma or equivalent
• Knowledge of cGMP practices including good documentation practices, data integrity and regulatory compliance
• Demonstrated ability to communicate with cross-functional teams including good oral and written communication skills
• Strong attention to detail
• Ability to work independently with minimal supervision
• Proficiency with computer systems including Veeva, MES, Microsoft Programs
• Responsible for maintaining a safe work environment, working safely & accountable for supporting all HSE Corporate, Project, and Site Goals
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., 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 experience with Manufacturing Execution Systems (MES) or electronic batch records
• Previous technical writing experience
• Technical aptitude and ability to train and mentor other team members

• 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
• May be required to respond to operational issues outside of core business hours and days
• May be subject to post-offer physical and vision exam
• Job is exposed to repetitive movements…