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.
Organization Overview:
Lilly manufacturing sites worldwide are introducing a number of next generation technologies and digital capabilities that will allow them to become the predictive and adaptive "digital plants of the future". With that innovation in mind, Lilly is designing and building a new state of the art parenteral, device assembly, and packaging facility located at the Research Triangle Park (RTP) in North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and quality system from the ground up.
Manufacturing and Quality Information and Digital Services (MQ IDS) 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 Information and Digital Solutions (IDS) Quality Control (QC) Systems Business Analyst position at Research Triangle Park (RTP) will partner with the quality control functional area and IDS to implement and support digital solutions that support the RTP manufacturing site.
Key Objectives/Deliverables:
Develop and maintain application knowledge and business context
Understand the business use of IDS applications within the quality control laboratory
Deliver and support digital solutions for the ongoing ramp-up of quality control lab
Work with global/local IDS and quality control teams to implement and maintain local responsibilities for system delivery (i.e. validation plans, standard operating procedures, training, etc.)
Build and maintain awareness and knowledge of regulatory, legal, or quality requirements impacting the quality control laboratory, and ensure compliance
Accurately translate business processes into technical terms and vice versa
Leverage knowledge of the quality control portfolio and IDS portfolio to develop and quantify business cases, to influence their adoption, and to measure the value gained from their implementation
Work with quality control to identify and capture new opportunities, improve processes, and optimize the value provided by IDS
Provide status reporting and manage issue escalations.
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 business need
Basic Requirements:
Bachelor of Science degree in IT, Chemistry, Pharmacy, Science, Engineering, or related field
At least 3 years 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 pharma or other GMP/GLP setting
Strong working knowledge of quality control laboratory IDS systems (i.e. Empower, SmartLab, Darwin, 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 ability to influence without authority
Demonstrated learning agilityand curiosity
Demonstrated ability to understand manufacturing business processes and convert into IT requirements/solutions
Demonstrated ability to evaluate, facilitate, and drive towards risk-based decision making
Desire and ability to communicate using a variety of methods in diverse forums
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