Associate - QA Representative - Floor

Position Description

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 manufacturing areas at Lilly’s new Concord, North Carolina site. The QA position is essential for ensuring GMP compliance in the design, delivery, verification, qualification, and start up to ensure regulatory approval of the facility.

As the project progresses, this role will transition to site-based process team supporting one of the following manufacturing areas:

• Formulation and Parenteral Manufacturing
• Device Assembly and Packaging Manufacturing
• Warehouse Logistics
• Facility, Utility and Maintenance

• Knowledge of cGMP practices including good documentation practices, data integrity and regulatory compliance
• Function as a cGMP liaison, working with Global Facility Delivery and Lilly project staff 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
• Consult with Network and Global quality groups 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 for the verification and qualification of the manufacturing buildings, including review of test cases, test execution, discrepancy resolution, etc.
• Work with the Site Quality Leadership to support the development of the vision and strategy for the overall site quality operation and cross‑functional support with focus on the Manufacturing 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 and training 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 including support of site self‑inspections in GQA
• Lead project initiatives needed in support of the project and Quality function
• Resolve or elevate any compliance issues to the project, site, and Quality Management
• Provides guidance for deviations, observation handling; change control proposals; document creation and revisions.
• Responsible for maintaining a safe work environment, working safely & accountable for supporting all HSE Corporate, Project, and Site Goals

• 3+ years’ experience in Quality pharmaceutical manufacturing required
• 5+ years’ experience in within the pharmaceutical or regulated manufacturing industry
• Bachelors or equivalent degree in a scientific field

• Previous experience with C&Q / Verification and Validation oversight including automation and computer systems validation
• Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing
• Demonstrated ability to communicate with cross‑functional teams including good oral and written communication skills
• Ability to work independently as a Quality SME with minimal supervision
• Proficiency with computer systems including Microsoft office products, Trackwise, etc.
• Responsible for maintaining a safe work environment, working safely & accountable for supporting all HSE Corporate, Project, and Site Goals
• Ability to work 8-12 hour shifts onsite (not eligible for remote work)
• Ability to work overtime as required
• ASQ Certified
• CSQA (Computer Systems Quality Assurance) experience
• Previous experience with manufacturing equipment prep, formulation, filling, and visual inspection, device assembly, packaging, utilities, facilities, maintenance, and warehouse management
• Previous experience with Manufacturing Execution Systems.
• Previ…