Lilly Quality Assurance Floor Support Supervisor in United States
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.
At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world’s greatest health challenges.
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 state-of-the-art facility and Quality System from the ground up.
The Quality Assurance Floor Supervisor is responsible for providing leadership to a team of QA Specialists, while reporting directly to the Quality Manager – DAP and Warehouse. The Quality Assurance Floor Supervisor provides support and QA oversight to GMP operations in the Device Assembly and Packaging (DAP) area. The QA Floor Supervisor works along with their team members supporting multiple production functions (from operations to maintenance) to achieve site goals while providing Quality oversight and ensure compliance.
Responsible for adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting HSE corporate and site goals.
Responsible for managing 6-10 Quality Specialists working across multiple shifts.
Responsible for ensuring team is trained and training remains in compliance.
Communicates with Quality Manager and Quality Representatives on quality and operational issues.
Ensures adherence and understanding of good documentation practices and compliance with applicable procedures for both Operations and Support personnel.
Lead, mentor, and coach Quality Specialists, Operations, and support personnel on quality matters, while driving the site Quality culture.
Ensures regular presence in device assembly and packaging areas to monitor GMP programs, and quality systems.
Ability to assess, create, and triage deviations / observations that occur within the device assembly and packaging areas.
Reviews and approves GMP documentation in support of daily operations such as:
·Maintenance Action Plans·Return to Service and Release of equipment, product, and area holds.·Spare parts consultation·Work order assessments and issue resolution·Other documents as required
Troubleshoot and provide QA systems support to reconcile issues in multiple systems (i.e., SAP, PMX. TrackWise, SmartLab, GMARS, Coldstream, and other systems as required.)
Participate in self-led inspections and provide support during internal / external regulatory inspections.
Effectively review and / or redline to ensure quality attributes are met. (i.e., deviations / observations, procedures, production records, validation protocols, change controls, and engineering documents).
Ability to work cross functionally and work collaboratively with all levels of the organization.
Demonstrated strong oral and written communication and interpersonal skills.
Demonstrated decision making and problem-solving skills.
Demonstrated knowledge and understanding of manufacturing process and Quality Systems.
Proficiency with inventory management systems and deviations systems, (i.e. SAP, Trackwise, etc.)
Strong attention to detail
Proven ability to work independently or as part of a team to resolve issues.
Ability to work overtime, as requested.
Ability to travel up to 10% to suppliers or other sites for meetings and coordination with global regulatory organizations.
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 start up experience.
Knowledge of Validation / Qualification activities.
High School Diploma or equivalent
Bachelor’s degree in a science, engineering, computer, or pharmaceutical related field of study is preferred.
May be required to respond to operational issues outside of core business hours / days.
Applicant may work in various areas within the DAP and Warehouse buildings. Mobility requirements should be considered when applying for this position.
This position is classified as a non-exempt role. Overall pay will consist of a competitive hourly rate plus any overtime and shift differential bonuses.
Position is first shift, but second shift work may be required as needed and will include a shift differential bonus.
Position may require a short duration assignment totaling 1-3 months in Indianapolis to establish specific device knowledge and establish global contacts.
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 ( LillyRecruitingCompliance@lists.lilly.com ) 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.
As a condition of employment with Eli Lilly and Company in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide valid proof of vaccination to the company.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!