Lead-Quality Assurance Floor Support Specialist; Nights

Overview

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 work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and contribute to communities through philanthropy and volunteerism. We put people first and seek individuals determined to make life better for people around the world.

Quality Assurance Floor Support Specialist (Nights)

At Lilly, we make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier lives. We also support communities through philanthropy and volunteerism.

Lilly is designing and building a new state-of-the-art Parenteral, Device Assembly, and Packaging Facility in Raleigh-Durham, North Carolina. This is an exciting opportunity to help build a quality system from the ground up.

The Quality Assurance Floor Support Specialist works as a member of the QA Floor Support team and reports to the QA Floor Support Supervisor. The role provides support and QA oversight to GMP operations in the Device Assembly and Packaging (DAP) area. The QA Floor Support Specialist supports multiple production functions (from operations to maintenance) to achieve site goals while providing Quality oversight and ensuring compliance.

• Adhere to safety rules and maintain a safe work environment for self and others by supporting HSE corporate and site goals.
• Ensure training is completed and remains in compliance.
• Communicate with QA Floor Support Supervisor and Quality Representatives on quality and operational issues.
• Ensure adherence to good documentation practices and compliance with applicable procedures for Operations and Support personnel.
• Lead, mentor, and coach Operations and support personnel on quality matters, driving the site Quality culture.
• Maintain regular presence in device assembly and packaging areas to monitor GMP programs and quality systems.
• Assess and create deviations/observations that occur within the device assembly and packaging areas.
• Review and approve GMP documentation in support of daily operations (e.g., Maintenance Action Plans, Return to Service and Release of equipment, product and area holds, spare parts consultation, work order assessments, issue resolution, and other documents as required).
• Troubleshoot and provide QA systems support to reconcile issues in multiple systems (e.g., SAP, PMX, Track Wise, Smart Lab, GMARS, Coldstream, and other systems as required).
• Participate in self-led inspections and provide support during internal/external regulatory inspections.
• Review and/or redline to ensure quality attributes are met (e.g., deviations/observations, procedures, production records, validation protocols, change controls, and engineering documents).
• Ability to work cross-functionally and collaborate with all levels of the organization.

• High School Diploma or equivalent
• Bachelor’s degree in a science, engineering, computer, or pharmaceutical related field of study, preferred.
• Completion of Post Offer Exam or Completion of Work Simulation if applicable.

• Demonstrated decision making and problem-solving skills.
• Strong attention to detail
• Proven ability to work independently or as part of a team to resolve issues.
• Ability to work overtime, as requested.
• Demonstrated strong oral and written communication and interpersonal skills.
• Demonstrated knowledge and understanding of manufacturing processes and Quality Systems.
• Proficiency with inventory management systems and deviations systems (e.g., SAP, Track Wise).
• Previous work with combination products or devices with experience with US/EU regulations and notified bodies.
• Previous experience in GMP production environments.
• Previous facility or area startup experience.
• Knowledge of Validation/Qualification activities.

• This position will support a 24/7 operation, working a rotating twelve (12) hour night shift schedule. During the project and onboarding phase,…