Principal Associate QA for QC

Eli Lilly and Company • Concord, NC

1d • Onsite

About The Position

Lilly is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to discovering and delivering life-changing medicines, improving disease understanding, and contributing to communities. The company is investing over $1 billion to establish a new, state-of-the-art manufacturing site in Concord, North Carolina. This facility will significantly boost manufacturing capacity for parenteral (injectable) medications, device assembly, and packaging operations, incorporating the latest high-tech equipment, advanced integrated and automated manufacturing systems, and a focus on environmental impact minimization. The Principal Associate - QA Laboratory Support role will initially involve demonstrating leadership, teamwork, and quality/regulatory oversight to guide and influence the design, instrumentation, system, and method validation for the laboratory areas during the site's startup phase. Following startup, the role will transition to providing site-based laboratory process team support, including daily execution oversight, guidance for non-conformance investigations, change control proposals, procedure revisions, and process improvements.

Requirements

• Bachelors or equivalent degree in a scientific field
• 2 - 3 years of QA or QC experience in pharmaceutical manufacturing (Microbiology experience is required)
• Ability to work 8 hour shifts M-F onsite (not eligible for remote work)
• Ability to work overtime as required
• Ability to travel 10-25% to support the design and staffing of the facility
• Qualified candidates must be legally authorized to be employed in the United States

Nice To Haves

• Commit to successfully maintaining Computer Systems Quality Assurance (CSQA) Certification
• Previous experience with laboratory instrumentation qualification, method transfer and routine product testing
• Demonstrated problem-solving and decision-making skills
• Previous experience supporting or using LIMS and LES systems
• Previous technical writing experience
• Previous facility or area start-up experience
• Technical aptitude and ability to train and mentor others
• Demonstrated knowledge and use of Compendial, 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.

Responsibilities

• Demonstrating leadership, teamwork, and quality and regulatory knowledge and oversight to provide guidance, consultation and influence in the design, instrumentation, system and method validation, for startup of the laboratory areas at Lilly’s new Concord, North Carolina site.
• Transition to site-based laboratory process team support for programs such as daily execution oversight and guidance for non-conformance investigations, change control proposals, procedure revisions, and process improvements as the project progresses.
• Consult with Network and Global quality groups as required to ensure consistent and compliant approach is executed during the project and startup phase.
• Lead, mentor and coach laboratory personnel on quality matters, including regular presence in the QC Laboratories areas to monitoring GMP programs and quality systems.
• Provide quality oversight for the qualification and validation of the laboratory buildings, systems and instrumentation; including review of test cases, test execution, discrepancy resolution, etc.
• Provide technical and quality review and approval of documents to ensure compliance with Lilly Global Quality Standards and local quality procedures.
• 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.
• Lead project initiatives in support of the project and Quality function.
• Resolve or escalate any compliance issues to the project, site, and Quality Management.
• Facilitates and coordinates training of new team members, prepares training materials as necessary.
• Provides guidance for deviations, observation handling; change control proposals; document creation and revisions.
• Responsible for maintaining a safe work environment, accountable for supporting all HSE Corporate, Project, and Site Goals.

Benefits

• Company bonus (depending, in part, on company and individual performance)
• 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
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Number of Employees: 5,001-10,000 employees