Lilly is looking for a QA Representative to provide leadership and quality guidance for the design, verification, and startup of manufacturing areas at our new Concord, North Carolina site. You will ensure GMP compliance for regulatory approval and will transition to support one of several manufacturing areas as the project progresses.
What You'll Do
- Function as a cGMP liaison, working with Global Facility Delivery and project staff to complete detailed design using QbD and QRM principles.
- Consult with Network and Global quality groups to ensure consistent and compliant project approach.
- Actively participate in required design reviews and final design qualification activities.
- Provide technical and quality review and approval of project documents for compliance with Lilly Global Quality Standards.
- Provide quality oversight for the verification and qualification of manufacturing buildings.
- Work with Site Quality Leadership to support development of the vision and strategy for overall site quality operation.
- Support building technical capability, including mentoring and training new Quality and project staff.
- Foster a strong quality culture including maintaining open communications and promoting teamwork.
- Support the definition and execution of inspection readiness activities including site self-inspections.
- Lead project initiatives needed in support of the project and Quality function.
- Resolve or escalate any compliance issues to project, site, and Quality Management.
- Provide guidance for deviations, observation handling; change control proposals; document creation and revisions.
- Maintain a safe work environment and support all HSE Corporate, Project, and Site Goals.
What We're Looking For
- 3+ years’ experience in Quality pharmaceutical manufacturing.
- 5+ years’ experience within the pharmaceutical or regulated manufacturing industry.
- Bachelors or equivalent degree in a scientific field.
Nice to Have
- 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 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.
- ASQ Certified.
- CSQA (Computer Systems Quality Assurance) experience.
- Previous experience with manufacturing equipment prep, formulation, filling, visual inspection, device assembly, packaging, utilities, facilities, maintenance, and warehouse management.
- Previous experience with Manufacturing Execution Systems.
- Previous use of KNEAT – or other electronic validation software.
- Previous technical writing experience.
- Technical aptitude and ability to train and mentor others.
Technical Stack
- Microsoft Office products
- Trackwise
- KNEAT or other electronic validation software
- Manufacturing Execution Systems
Team & Environment
This role will transition to a site-based process team supporting one of several manufacturing areas.
Benefits & Compensation
- Compensation: $65,250 - $169,400
- Company bonus (depending on company and individual performance)
- Comprehensive benefit program
- Eligibility to participate in company-sponsored 401(k)
- Pension
- Vacation benefits
- 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, employee clubs and activities)
Work Mode
This is an onsite position based in Concord, North Carolina.
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.
