Computer Systems Quality Assurance Specialist

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 35,000 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. Job Description Organization Overview: Each Lilly employee will embrace Operational Excellence in everything we do, to achieve our mission of Making Medicine with Safety First & Quality Always; following our common purpose under TEAM Lilly and our Manufacturing Standards under the strict code of conduct guided by our Red Book assuring data integrity in all we do in order to deliver a reliable supply of medicine for people around the world. Position Brand Description: Primary function: Independently work within the Lilly Branchburg Process Team environment per Manufacturing Standards for Operational Excellence (MSOE) to perform system audit trail reviews of site-wide systems, working with functional area subject matter experts to resolve key technical/quality issues. Additional functions may include: Lead medium-scale projects or programs with moderate risk and/or complexity. Provide assistance to cross-functional groups and/or management with troubleshooting investigations and problem resolution. Assist with implementation of quality improvement plans. Ensure regulatory compliance and procedural consistency between manufacturing facilities. Prepares cross-functional partners for Regulatory Inspections. Provides assistance, where necessary, during regulatory/partner inspections. Ensures compliance observations associated with Lilly Branchburg Manufacturing Facilities are adequately addressed and completed on schedule Key Objectives/Deliverables: Specialist or Principal – Computer Systems Quality Assurance (CSQA) Perform System Audit Trail Reviews. Review and approval of computer system (automation) related work orders. Review and approval of computer system related Standard Operating Procedures (SOP). Lead the investigation and evaluation of computer system related incidents and/or deviations. Serve as a lead auditor during audits of software suppliers and/or computer related service providers, when required. Must have a thorough understanding of computer systems validation as outlined in GAMP or an understanding of the System/Software Development Life Cycle concepts. Must be willing to travel domestically and internationally to support audits of software vendors or vendors that provide computer related services to the site. Manage for Results /Strategic Planning: Evaluate deviations and ensure appropriate root cause/likely assignable cause(s) and assess quality impact. Recommend CAPAs and ensure CAPAs implemented are effective. Review and approve respective development and validation documentation. Evaluate change controls and associated risk assessments. Perform training within group or throughout organization as needed. Write/escalate Notifications to Management, as applicable. Ensure timely completion of all quality plan objectives and milestones. Support the on-time performance metrics. Assist in creating quality metrics. Keep Quality management informed of compliance issues. Attend and serve as a key resource in ad-hoc meetings to provide compliance guidance to Manufacturing, Facilities, Validation, Computer Systems issues. Support lot release through ensuring timeliness resolve of compliance issues, as applicable. Ensure compliance with applicable regulatory guidelines and GxP computer systems to global electronic records/signatures regulations (21 CFR Part 11, Annex 11, etc. as applicable); Perform review of regulatory submissions as necessary. Perform the compliance and risk evaluation of respective systems and departments. Participate in internal audits performed by partners, Lilly corporate, and/or regulatory agencies, as applicable. Identify and lead a process improvement projects that impact systems used in a specific functional area. Perform Analysis Audit Trail Reviews. Basic Requirements: BA/BS degree in the sciences with a minimum of 1-3 years experience in the Biopharmaceutical industry. Previous technical experience should be in biotechnology manufacturing processes and/or computer systems (large scale cell culture, purification processes, validation). Additional Preferences: Must possess working knowledge of domestic and international GMP regulations and other policies/regulations as applicable. Must have experience in developing, reviewing and/or approving the following types of development/validation documents: Validation Plans, User/Functional Requirement Specifications, IQ/OQ/PQ Protocol and Reports, Requirements Traceability Matrix, and Validation Summary Reports. Must possess a conceptual understanding of all Quality functions and business areas. Must possess depth and/or breadth of expertise within area of responsibility. Must have the ability to function in a fast-paced environment and communicate effectively with management. Must be able to work in a cross-functional environment. Must have demonstrate ability to work independently. Must be proficient in Microsoft applications. Additional Information: Travel required, approximately 10%. Lifting not required. Required to be on call. Shift work may apply. 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. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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. As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law). #WeAreLilly