Overview
QA Representative – Floor Jobs in Concord, North Carolina, USA at BioSpace
Position: QA Representative – Floor Support
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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 work worldwide to discover and bring life-changing medicines to those in need, improve disease understanding and management, and give back through philanthropy and volunteerism. We strive to put people first and are seeking individuals committed to making life better globally.
Position Description
The Quality Assurance Representative is responsible for applying quality/regulatory knowledge to guide, consult, and influence in the design, verification, and startup of manufacturing operations at Lilly’s new Concord, NC site. The role requires leadership and teamwork to ensure cGMP compliance and regulatory approval through all phases of design, delivery, verification, qualification, and startup activities. The QA Representative will also support Device Assembly and Packaging (DAP) manufacturing areas as the startup progresses.
Responsibilities Include
Maintaining knowledge of current Good Manufacturing Practices (cGMP), including GDP, data integrity, and regulatory compliance.
Fostering a strong quality culture through open communication, teamwork, and employee participation.
Guiding others on Quality Management System (QMS) topics such as deviations, CAPA, change controls, and document management.
Supporting inspection readiness activities, including site self-inspections.
Resolving or escalating compliance issues to appropriate levels.
Serving as a cGMP liaison, working with global teams to ensure design and quality system integration.
Consulting with global quality groups to ensure a compliant startup approach.
Participating in design reviews and qualification activities.
Reviewing project documents for compliance with Lilly standards and procedures.
Overseeing verification and qualification of manufacturing facilities, including testing and discrepancy resolution.
Supporting site quality strategy development and technical capability building.
Mentoring and training staff in quality practices.
Leading initiatives to support startup and quality functions.
Maintaining a safe work environment in compliance with HSE goals.
Basic Requirements
Bachelor’s degree or equivalent.
Ability to work 12-hour shifts on a 2-2-3 schedule, with additional hours as needed.
Onsite work in Concord, NC (not remote).
Additional Skills/Preferences
Experience in pharmaceutical, medical device, or regulated manufacturing industries.
Experience supporting pharmaceutical or medical device manufacturing as a quality professional.
Knowledge of US, EU, Japan regulations.
Strong communication skills for cross-functional teamwork.
Ability to work independently as a Quality SME.
Proficiency with systems like Microsoft Office and Trackwise.
ASQ Certification; CSQA experience.
Experience with manufacturing equipment, validation software like KNEAT, and technical writing.
Experience with C&Q/Validation including automation and computer systems.
Legal authorization to work in the US; sponsorship not available.
Lilly is committed to diversity and inclusion and provides accommodations for applicants with disabilities. For assistance, complete the workplace accommodation form. We are an equal opportunity employer and do not discriminate based on age, race, gender, or other protected categories.
Compensation for this role ranges from $63,000 to $140,800 annually, depending on experience, education, and location. Benefits include bonuses, 401(k), health insurance, paid time off, and more.
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Title: QA Representative – Floor
Company: BioSpace
Location: Concord, North Carolina, USA
Category: Quality Assurance – QA/QC, Healthcare