Lead - Quality Assurance Floor Support Specialist (Nights)

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.

Job Description: Quality Assurance Floor Support Specialist (Nights)

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to 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 state-of-the-art facility and Quality System from the ground up. 

Responsibilities:

The Quality Assurance Floor Support Specialist works as a member of the QA Floor Support team and reports to the QA Floor Support Supervisor. QA Floor Support Specialist is responsible for providing 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.  

Key Objectives/Deliverables:

• 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 ensuring training is completed and remains in compliance.
• Communicates with QA Floor Support Supervisor 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 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 and create 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 and 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.

Basic Requirements:

• 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.

Additional Preferences:

• 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 process and Quality Systems.
• Proficiency with inventory management systems and deviations systems, (i.e. SAP, Trackwise, etc.)
• 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.

Additional Information:

• This position will support a 24/7 operation, working a rotating twelve (12) hour nightshift schedule.  During the project and onboarding phase, role will work eight (8) hours Monday-Friday dayshift, then transition to the rotating twelve (12) hour nightshift stated above upon approval from Supervision/Management.
• 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.
• Position is for nightshift, but dayshift work may be required.
• Position may require a short duration assignment of 1-3 months in Indianapolis to establish specific device knowledge and establish global contacts.

Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$28.84 - $46.54

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including 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).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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