QA Compliance Associate – CSV and Data Management

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

$63,000 - $140,800

Organization 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

Key Objectives/Deliverables/Responsibilities

• Ensure RTP’s computer system program is established and compliant with LQS302 Computer Systems including IDS, Automation, and laboratory computer system lifecycle management programs.
• Review and approve documents per CSV expectations within agreed service levels, or clearly communicate when activities will be completed.
• Acts as site Business QA for the QA Data Systems ensuring data integrity, accuracy, and reliability throughout the data lifecycle. Implement and maintain data management processes and systems.
• Serve as a local training instructor for the QA Data Systems
• Create, revise and approve site compliance area documents, including specifications and procedures
• Collaborate with cross-functional partners, such as Manufacturing operations, TS/MS (Technical Sciences / Manufacturing Sciences), Engineering, Logistics, and QC Labs, to streamline processes and sustain customer service
• Investigate non-conformances associated with QA data systems
• Approve GMP documents (examples: Minor non-conformances, procedures and change controls)
• Analyze large data sets, identify trends and patterns, informing decision making and improving quality processes. Generate regular and ad-hoc reports to document compliance status and findings.
• Create visual representations of data to communicate insights and the compliance status of the Site Quality Metrics to the Site Leadership Team
• Facilitate Site Quality Metrics reviews within Site Quality Lead Team
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
  
  
  

Basic Requirements

• Bachelor’s degree in engineering, computers, or science related field.
• At least 5 years working in the pharmaceutical or medical device industry in QA or CSV roles
  
  
  

Preferred Attributes But Not Required

• Proficiency with GMP computer systems validation including regulations governing them
• Previous CSQA / CSV experience
• Demonstrated strong oral and written communication and interpersonal interaction skills
• Demonstrated strong technical writing skills
• Ability to compile/analyze data and metrics in reports understandable by management and business partners.
• Attention to detail, self-management, problem solving; mentoring.
• Previous experience with Quality management systems including TrackWise and Veeva.
• Previous experience with device and parenteral product materials
• Previous experience with deviation and change management systems including TrackWise/Veeva
  
  
  

Other Information

• Ability to work 8-hour days – Monday through Friday is required on site; up to 4 days per month (e.g. 1 day per week) may be WFH applicable.
• May require support outside of regular schedule (weekend days or off-hours) in support of continuous (24/7) manufacturing operations.
• Ability to travel up to 5% to Indianapolis, IN for meetings and coordination with global regulatory organizations is 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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