QA Associate – Computer Systems

Location Type: On-site

 

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.

Description:
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.
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.
Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 billion to create a new state-of-the-art manufacturing site, in Concord, North Carolina. The brand-new facility will utilize the latest technology to increase the company’s manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. This role will function as a Computer System Quality Assurance (CSQA) / Computer System Validation (CSV) Subject Matter Expert, working with Global Facility Delivery, Lilly project staff, Global CSQA, and selected External Contracting firms to complete delivery of the Concord site employing Quality by Design (QbD) and Quality Risk Management (QRM) principals and ensuring the integration of Global Quality System requirements.

Responsibilities:

• Interact with the other global, project and functional areas to coordinate design and start up activities to support the overall project and site schedule
• Consult with Network and Global quality groups as required to ensure consistent and compliant approach is executed during the project and startup phase
• Provide technical and quality review and approval of project computer system documents to ensure compliance with Lilly Global Quality Standards as well as project and local quality procedures
• Provide quality oversight for the verification and qualification of systems, including review of test cases, test execution, discrepancy resolution, etc. and assure that validation artifacts follow Good Documentation Practices.
• Assure computer systems (including but not limited to IT systems, Lab Automation, M&Q Automation) meet Lilly standards and Quality Procedures conforming regulatory expectations.
• Assist and/or lead Data Integrity (DI) related projects for the Concord site:
• Participate in Audit Trail Review of Computer Systems and adhere to Global Lilly Standards
• Participate in DI Assessment of Computer Systems, Interfaces, Processes to identify any potential data vulnerabilities in the design of the systems
• Support the site organization in building technical capability, for a diverse cross-functional staff in Quality, the project team, and area process teams, including mentoring of new Quality and other project staff
• Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group
• Manage CSQA priorities, schedules to assure timely delivery of CSQA and Lilly – Concord objectives.
• Establish partnership with the Technology Team, system owners, business owners and provide rationale with data/ Lilly guidance / priorities, etc.
• Lead project initiatives needed in support of the project and Quality function
• Resolve or escalate any compliance issues to the project, site, and Quality Management
• Support the QA Compliance team and site in the execution of the site readiness plan with focus on supporting start-up and ongoing quality oversight of site Computer Systems
• Participate in self-led inspections and provide support during internal/external regulatory inspections
• Ability to effectively review and / or redline documents to ensure quality attributes are met (i.e., deviations / observations, procedures, technical studies, validation protocols, change controls, and engineering documents)

Basic Requirements:

• At least 3 years working in the pharmaceutical or medical device industry in QA or CSV roles
• Bachelor’s degree in engineering or computers preferred or Science related field
• Previous CSQA / CSV experience
• Proficiency with GMP computer systems validation including regulations governing them
• Demonstrated strong oral and written communication and interpersonal interaction skills
• Demonstrated strong technical writing skills
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals
• Work independently and engage with assigned business areas in operational decisions on behalf of Quality organization.
• Ability to work 8-hour days on site – Monday through Friday
• Ability to work overtime as required
• Ability to travel up to 10% for meetings and coordination with global regulatory organizations

Additional Skills/Preferences:

• Previous facility or area start up experience
• Previous experience with Global IT system / tool validation
• CQA certification from the American Society for Quality (ASQ)

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

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 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.

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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