About the position
Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced quality assurance associates to support our growth in Kenosha County, Wisconsin. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies. The Senior Associate, Quality Assurance – Data Steward is responsible for improving business processes and supporting customer service interactions to ensure key business objectives are met. The QA Data Steward represents Quality Assurance on projects, including six sigma. Finally, the QA Data Steward is responsible for activities that include SAP master data management, change management, deviation management, procedure management, review of specifications, review and approval of cGMP documents, and maintaining regulatory compliance.
Responsibilities
- Support the site in the development and execution of the site readiness plan with focus on supporting startup of new systems and oversight of the establishment of site master data.
- Support the implementation, validation and maintenance of the software based computerized quality systems for the site.
- Serve as the Power User for IT systems supported by QA including LIMS, Manufacturing Execution System, SAP, TrackWise, Veeva Suite.
- Create and manage quality master data in SAP including q-info records and inspection plans for materials.
- Protect the integrity and accuracy of data to be entered into the quality systems, perform data identification and reviews as required.
- Lead, mentor and coach site personnel on data management and the quality systems.
- Responsible for site compliance area documents such as procedures.
- Partners and builds relationships with Global Quality Network and Global IT team members.
- Provides oversight and supports continuous improvement of quality systems.
- Support onboarding of new materials in TrackWise.
- Effectively review/approve GMP documents to ensure quality attributes are met (e.g., deviations, procedures, protocols, specifications, change controls).
- Participate in self-led inspections and/or provide support during internal inspections.
- Support regulatory inspection activities as needed by providing documentation and SME support.
Requirements
- Bachelor's degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience.
- Minimum 5 years in the pharmaceutical industry with specific data stewardship experience.
- On-site presence required.
Nice-to-haves
- Demonstrated understanding of cGMP regulations.
- Previous experience in GMP production environments.
- Proficiency with applicable computer systems including SAP, Master Control, Trackwise, and Veeva.
- Demonstrated strong oral and written communication skills.
- Demonstrated interpersonal skills and the ability to work as a team.
- Ability to influence internally and externally.
- Root cause analysis/troubleshooting skills.
- Demonstrated attention to detail and ability to maintain quality systems.
- Proven ability to work independently or as part of a Team to resolve an issue.
- Technical writing and communication skills.
- Previous regulatory inspection readiness and inspection execution experience.
- Knowledge of operations business processes such as batch disposition, materials management, laboratory specification/method management.
- Previous experience with SAP or other inventory management systems.
- Previous experience with device, packaging, and parenteral product materials.
Benefits
- 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.
- Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).
