Lead Technician - QA Data Steward

We’re looking for people who are determined to make life better for people around the world.

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.

Position Description :

The QA Data Steward within Indianapolis Parenteral Manufacturing is responsible for the creation / verification of Certificates of Analysis for semi-finished and finished commercial batches.

In addition, the QA Data Steward is responsible for oversight of critical data maintained within one or more automated system, such as SAP, TrackWise, QualityDocs / Veeva, and Darwin.

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.

Key Objectives / Deliverables :

• 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 and performance of system audits, as required
• Process revisions / creations of QualityDocs / Veeva Specifications, as required, per approved Change Controls and RCM Matrix 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 analyses for changes with impact to SAP, Veeva, and / or Darwin records
• Create / Verify Certificates of Analysis for semi-finished and finished commercial batches
• Support projects / initiatives that may impact data stewardship processes and procedures, as needed

Minimum Requirements :

• Experience working in SAP, TrackWise, QualityDocs / Veeva, 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 Preferences :

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

Education Requirements :

High School Graduate or equivalent.

Other Information :

• Shift schedule : Monday-Friday 8am-5pm
• Overtime may be required.
• May be required to support off shift activities related to operational issues.
• Applicant may work in various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant. Mobility requirements and exposure to allergens should be considered when applying for this position.
• Minimal travel required
• May be subject to Post Offer Exam

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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