Entry Level Quality Assurance Associate

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. The brand-new facility will utilize the latest technology to increase the company's manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. This is an exciting once-in-a-lifetime opportunity to help build and operate a new site. The Lilly Concord site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. The Principal Associate - QA Laboratory Support is responsible for 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. As the project progresses, this role will 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.
Knowledge of cGMP practices including good documentation practices, data integrity and regulatory compliance
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; 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.
document creation and revisions.

3 years QA or QC experience in pharmaceutical manufacturing required
~Demonstrated knowledge and use of Compendial, US, EU, Japan and other regulations in the area of pharmaceutical manufacturing
~ 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, accountable for supporting all HSE Corporate, Project, and Site Goals
~ Ability to work 8 hour shifts M-F onsite (not eligible for remote work)
~ Ability to work overtime as required
~ H-1B or TN status) for employment positions on the B or S paths or at levels M1-M2 or R1-R3.

Bachelors or equivalent degree in a scientific field

Commit to successfully maintaining Computer Systems Quality Assurance (CSQA) Certification
Previous experience with laboratory instrumentation qualification, method transfer and routine product testing
Previous technical writing experience
Previous facility or area start-up experience
Ability to travel 10-25% to support the design and staffing of the facility.

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