Sr. Principal - QA at Eli Lilly and Company

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Overview:

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.

Responsibilities:

The primary responsibilities of the QA Engineer are to assure compliance with corporate quality systems and current GMPs for the Operations of IDAP. This position provides quality oversight of the Production Quality System in support of operations, including assistance and mentorship in the execution of change controls, equipment qualification, process validation, computer system quality, deviations, and complaint investigations. This assignment will involve a high level of engagement with Operations, Engineering, and area Leadership.

• Promote safety awareness
• Remain current with individual training plan
• Observe, promote, and follow requirements related to safety, quality, security, customer service, and GMPs
• Provide consultation and interpretation of quality guidance documents regarding qualification / validation, cleaning, change control, production practices, deviations, CSQ, and complaint management
• Provide quality oversight and provide quality support for bringing new products into IDAP
• Provide quality oversight of the IDAP operations and processes to support QA Floor Reps / QA Technicians floor decisions
• Raise notification to management for departures of critical nature and assure issues are addressed
• Assess gaps between local and corporate standards and facilitate remediation efforts actively working with support areas
• Ensure area is always audit ready
• Support project timelines assuring compliance with Quality expectations
• Proactively work with areas to provide support and promote consistency with Quality expectations and discuss resolution with process team members
• Possess a detailed understanding of the IDAP processes including critical parameters, components used, equipment, etc.
• Actively assist in continuous improvements and efficiency projects
• Provide quality impact assessments, reviews and approvals on validation protocols, qualification documents, change controls, deviations, holds, procedures, and maintenance work orders related to the IDAP processes
• Actively seek expanded knowledge of applicable technologies, processes, and regulations through training, networking, floor presence, and project participation
• Provide leadership in communicating cGMP requirements to shop floor and promote best practices through direct contact with production, maintenance, engineering, and automation

Basic Qualifications:

• Bachelor's Degree (STEM related degree preferred) or equivalent experience

Additional Skills/Preferences:

• 3 or more years' experience in a GMP environment preferred
• Previous experience in Quality Assurance or Engineering preferred
• Knowledge of cGMPs, Production Processes, Quality Systems, and FDA regulations
• Experience supporting computer systems (e.g. CSV, CSQ, IDS experience)
• Proficiency with computer systems such as TrackWise, SAP, PMX, and Quality Docs
• Experience in conducting root cause investigations, and execution of change management, equipment qualification, and process validation
• Ability to communicate effectively with customers to carry out requirements
• Ability to work under time pressure, exert good judgment in special situations, make decisions independently under minimum supervision, and problem solve
• Ability to influence team interactions and lead initiatives
• Demonstrated strong oral and written communication and interpersonal skills
• Demonstrated decision making and problem-solving skills
• Demonstrated knowledge and understanding of manufacturing process and Quality Systems
• Demonstrated attention to detail
• Demonstrated ability to coordinate and prioritize multiple tasks.

Additional Information:

• Flexibility is required as work hours and start times may vary to provide coverage on different shifts to meet business needs
• Overtime and weekend work may be required.
• Individual must be available via cell phone (on-call)
• Applicant may work in various areas within the IDAP Plant. Some allergens are present in the IDAP Plant. Mobility requirements and exposure to allergens should be considered when applying for this position.
• Some travel may be required

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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