Scientist - QA Parenteral
About The Position
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. Lilly has built a new state of the art Parenteral, Device, and Packaging Assembly Facility in Raleigh-Durham North Carolina. The Quality Assurance Representative is responsible for demonstrating leadership, teamwork, and quality and regulatory knowledge and oversight to provide guidance, consultation and influence in the design, verification, and startup of the parenteral areas. The QA parenteral project role is essential for ensuring GMP compliance in the design, delivery, start up to ensure regulatory approval of the facility by regulatory agencies. Key Objectives/Deliverables: Act as a cGMP expert, working with Global Facility Delivery, Lilly project staff, and selected A&E firm to complete the detailed design of the assigned areas employing QbD and QRM principals and ensuring the integration of Global Quality System requirements into the design, verification, validation and start up. 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 groups including the GQS, ETC, GPP and SAT Hub as required to ensure consistent and compliant approach is executed during the project and startup phase. Actively participate in required design reviews and final design qualification activities. Provide technical and quality review and approval of project documents to ensure compliance with Lilly Global Quality Standards as well as project and local quality procedures. Provide quality oversight of verification and validation activities Work with the Site Quality Leader to support the development of the vision and strategy for the overall site quality operation with focus on the Parenteral areas. 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. Support the definition and execution of inspection readiness activities. 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.
Requirements
- At least 5 years of quality knowledge and expertise in parenteral manufacturing and quality.
- Previous experience with C&Q / Verification and Validation oversight including computer systems.
- Ability to work 8 hour days – Monday through Friday
- Ability to work overtime as required.
- Available off shift to respond to operational issues.
- Ability to travel up to 10% of the time.
Nice To Haves
- Previous quality knowledge and oversight of parenteral manufacturing operations.
- Previous experience with capital project delivery.
- Previous experience with parenteral equipment prep, formulation, filling, and visual inspection.
- Previous experience with barrier or isolator technologies
- Previous experience with Manufacturing Execution Systems.
- Previous experience with global parenteral platforms (Cartridge, Syringe, or Vial)
- Previous experience with automated and IT systems
- Previous use of KNEAT – or other electronic validation software.
- Previous computer system oversight.
- Strong technical aptitude and ability to train and mentor others.
- Demonstrated ability to communicate with cross-functional teams including good oral and written communication skills.
- Ability to work independently as a Quality SME with the project team with minimal supervision.
- Proficiency with computer systems including Microsoft office products, Trackwise, Veeva, etc.
Responsibilities
- Act as a cGMP expert, working with Global Facility Delivery, Lilly project staff, and selected A&E firm to complete the detailed design of the assigned areas employing QbD and QRM principals and ensuring the integration of Global Quality System requirements into the design, verification, validation and start up.
- 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 groups including the GQS, ETC, GPP and SAT Hub as required to ensure consistent and compliant approach is executed during the project and startup phase.
- Actively participate in required design reviews and final design qualification activities.
- Provide technical and quality review and approval of project documents to ensure compliance with Lilly Global Quality Standards as well as project and local quality procedures.
- Provide quality oversight of verification and validation activities
- Work with the Site Quality Leader to support the development of the vision and strategy for the overall site quality operation with focus on the Parenteral areas.
- 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.
- Support the definition and execution of inspection readiness activities.
- 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.
Benefits
- employees also will be eligible for a company bonus (depending, in part, on company and individual performance)
- 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).
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
