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.
supports manufacturing operational excellence and productivity efforts through utilization of information and technology. MQ IDS strives to enable the making of medicine "with safety first and quality always".
Responsibilities:
This Quality Control & Quality Assurance Systems Analyst position at Research Triangle Park (RTP) will partner with the quality control functional area and global teams to implement and support digital laboratory solutions that support the RTP manufacturing site.
Key Objectives/Deliverables:
- Develop application knowledge and business context
- Understand the business use of applications within the quality control laboratory
- Understand the business use of applications within the quality assurance
- Accurately translate business processes into technical terms and vice versa
- Build and maintain awareness and knowledge of regulatory, legal, or quality requirements impacting the quality control laboratory and quality assurance, and ensure that solution requirements comply
- Deliver and support digital solutions to start up new quality control lab
- Work with global system teams to understand and implement local responsibilities for system delivery (i.e. validation plans, standard operating procedures, training, etc.)
- Produce and maintain project and validation documentation
- Ensure systems remain in a validated state and manage their lifecycle through releases, recapitalization, and retirement
- Ensure the incident, problem, configuration, and change/release management are all accomplished in alignment with and understanding of business need
Minimum Requirements:
- Bachelor of Science degree in IT, Chemistry, Pharmacy, Science, Engineering, or related field
- At least 1 year of relevant work experience in information technology, engineering, computer system validation, quality control support or related areas
Additional Skills/Preferences:
- Prior work experience working in pharmaceuticals or other GMP setting
- Strong working knowledge of quality control laboratory systems (i.e. Empower, SmartLab, Darwin, LabVantage, etc.)
- Strong working knowledge of quality assurance systems (i.e. Veeva QualityDocs, Tulip, etc.)
- Solid knowledge of Computer System Validation process
- Demonstrated ability to analyze, anticipate, and resolve complex issues (technical, operational, or business-related) through sound problem-solving skills
- Effectively prioritize and escalate issues
- Demonstrated learning agility and curiosity
- Demonstrated ability to understand quality control business processes and convert into IT requirements/solutions
- Desire and ability to communicate using a variety of methods in diverse forums
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 ( ) 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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$63,750 - $145,200
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.