Associate - QA Representative

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:

The QA Data Steward is responsible for oversight of critical data maintained within one or more automated system, such as SAP, TrackWise, QualityDocs, and Darwin. QA Data Steward is responsible for providing site metrics, training, and audits of these systems, as needed. The QA Data Steward performs impact analyses, ensures all data changes are properly documented and controlled, implements/verifies system changes, and performs system audits, where applicable, to ensure data integrity. QA Data Steward is responsible for improving business processes, supporting customer service interactions, and support of audits to ensure key business objectives are met.

Responsibilities:

• Provide oversight and implement/verify changes of Q-Info Records and Inspection Plans in SAP.
• Provide oversight of the TrackWise system, including the processing of records, performance of system audits, and provide CAPA training, as required.
• Process revisions/creations of material Specifications, as required, per approved Change Controls, APR actions, and Veeva RIM revisions.
• Process revisions/creations of Darwin product, specification, test allocation, and sampling plan master data records within the Darwin LIMS system.
• Perform timely, accurate impact analysis for changes with impact to SAP, QualityDocs, and/or Darwin records.
• Support projects/initiatives that may impact data stewardship processes and procedures, as needed.
• Communicate best practices for CAPA process, ensure compliance with procedures, process, and work instructions.
• Provide guidance and recommendations to IDAP Site associates in support of remediation of significant quality issues and compliance gaps.
• Participate as required in teams, committees, or other groups to resolve quality issues and ensure site compliance to Lilly Standards and external regulations.

Basic Requirements:

• Experience working in SAP, TrackWise, QualityDocs, and/or Darwin.
• Strict attention to detail and ability to maintain compliance issues and meeting critical deadlines.
• Overall business understanding including proposal of changes, implementation, and related regulations; and pharmacopoeia requirements.
• Excellent written and oral communication skills, troubleshooting and investigating skills, and crisis decision-making skills.
• Strong organizational skills - ability to handle/prioritize multiple projects and requests.
• Ability to interact effectively with a variety of people - good teamwork skills.

• Effective training skills and ability to coach others.
• Familiarity with cGMPs and corporate policies and procedures.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

Additional Skills/Preferences:

• General understanding of quality, logistics, and/or operations techniques and terminology.
• Previous experience in operations, quality, quality control, and/or logistics.
• Proficient in Microsoft Word/Excel/Power Point.

Education Requirements:

• Bachelors (or equivalent) degree in a scientific field or equivalent work experience.

Additional Information:

• Overtime may be required.
• May be required to respond to operational issues outside of core business hours and days.
• Applicant may work in various areas within the IDAP Plant. Some allergens are present in the IDAP Plant.
• Minimal travel required.
• May be subject to Post Offer Exam.

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 ( [email protected] ) 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.

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