Qa Floor Support Supervisor - Parenteral

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.

Organization Overview:

Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility in Concord, 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 Support Lead is responsible for providing leadership to a team of QA Specialists, while reporting directly to the Associate Director – QA Parenteral. The Quality Assurance Floor Support Lead provides support and QA oversight to GMP operations in the formulation, filling and visual inspection process areas.  The QA Floor Support Lead 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.
Responsibilities:

• 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 supporting parenteral operations with the specialist working across multiple shifts.
• 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, such as aseptic practices, while driving the site Quality culture.
• Ensures regular presence in preparation, formulation, filling and visual inspection areas to monitor GMP programs, and quality systems.
• Responsible for ensuring team is trained and training remains in compliance.
• Ability to assess, create, and triage deviations / observations that occur within the parenteral 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 documentation as required.
• Troubleshoot and provide QA systems support to reconcile issues in multiple systems (i.e., SAP, PMX. TrackWise, SmartLab, GMARS, and other systems as required.)
• Participate in self-led inspections and provide support during internal / external regulatory inspections.
• Review and / or redline to GMP documents ensure quality attributes are met. (i.e., deviations / observations, procedures, production records, etc.).
• Communicates with Associate Director and Quality Representatives on quality and operational issues.
• Work cross functionally and collaboratively with all levels of the organization.

Basic Requirements:

• High School Diploma or equivalent
• 5 years experience in quality leader role supporting parenteral manufacturing operations

Additional Skills/Preferences:

• Bachelor’s degree in a science, engineering, computer, or pharmaceutical related field of study, preferred.
• 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.

Additional Information:

• Position is first shift, but second shift work may be required. 
• May be required to respond to operational issues outside of core business hours / days.
• Ability to work overtime, as requested
• Applicant may work in various areas within Parenteral Building. Mobility requirements should be considered when applying for this position.
• Ability to travel up to 10% to other sites for meetings and coordination with global organizations.
• Position may require a short duration assignment of 1-3 months in Indianapolis to establish specific parenteral line  knowledge and establish global contacts.

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