At our organization, we are driven by a unified mission: to merge compassion with innovation to enhance lives worldwide. As a leading global healthcare organization headquartered in Indianapolis, Indiana, we strive to discover, develop, and deliver groundbreaking medicines that empower individuals to lead longer, healthier, and more fulfilling lives. Our commitment extends beyond pharmaceutical breakthroughs; we actively engage in philanthropy and volunteerism to support communities worldwide. Rooted in our core values, we prioritize both excellence in our work and the well-being of people, always placing them at the forefront of our endeavors. We are seeking individuals who share our dedication to making a positive impact on the world.
Organization Overview:
At our organization, we are driven by an extraordinary purpose: to make a meaningful difference in the lives of people worldwide by pioneering, producing, and providing medications that promote longer, healthier, and more active lifestyles. In addition to our innovative pharmaceuticals, you can rely on us to devise inventive solutions to support communities through charitable contributions and volunteer efforts.
Job Description:
As a Quality Assurance Representative, you will play a pivotal role in demonstrating leadership, fostering teamwork, and applying your expertise in quality and regulatory affairs. You will provide invaluable guidance, consultation, and influence in the design, verification, and launch of manufacturing operations at our newly established site in Concord, North Carolina. Ensuring compliance with Good Manufacturing Practices (GMP) throughout the project lifecycle is essential for securing regulatory approval of the facility. As the project evolves, your role will transition to providing on-site support for one of the following manufacturing areas:
Formulation and Parenteral Manufacturing
Device Assembly and Packaging Manufacturing
Warehouse Logistics
Facility, Utility, and Maintenance
Responsibilities:
Demonstrate proficiency in cGMP practices, encompassing good documentation practices, data integrity, and regulatory compliance.
Serve as a cGMP liaison, collaborating with Global Facility Delivery and project teams to finalize the detailed design of designated areas, incorporating Quality by Design (QbD) and Quality Risk Management (QRM) principles.
Consult with Network and Global quality groups to ensure consistent and compliant execution throughout the project and startup phases.
Actively participate in design reviews and final design qualification activities.
Provide technical and quality review and approval of project documents to ensure alignment with Global Quality Standards and local quality procedures.
Offer quality oversight for the verification and qualification of manufacturing buildings, including reviewing test cases, overseeing test execution, and resolving discrepancies.
Collaborate with Site Quality Leadership to shape the vision and strategy for overall site quality operations, emphasizing support for manufacturing areas.
Aid in building technical capabilities across a diverse, cross-functional staff in Quality, project teams, and area process teams through mentoring and training initiatives.
Cultivate a robust quality culture by fostering open communication, promoting teamwork, and encouraging employee participation within the workgroup.
Contribute to defining and executing inspection readiness activities, including site self-inspections in Global Quality Assurance (GQA).
Lead project initiatives essential for supporting both the project and Quality function.
Proactively address compliance issues by resolving them or escalating them to project, site, and Quality Management.
Provide guidance on deviations, observation handling, change control proposals, and document creation and revisions.
Basic Requirements:
Bachelor's degree or equivalent in a scientific field.
Prior experience in quality within pharmaceutical manufacturing is essential.
Previous involvement in Commissioning and Qualification (C&Q) / Verification and Validation oversight, including automation and computer systems validation.
Demonstrated familiarity with US, EU, Japan, and other relevant regulations pertaining to pharmaceutical manufacturing.
Strong communication skills, both oral and written, with the ability to engage effectively with cross-functional teams.
Capacity to work independently as a Quality Subject Matter Expert (SME) with minimal supervision.
Proficiency with computer systems, including Microsoft Office products and TrackWise.
Responsible for maintaining a safe work environment, adhering to safety protocols, and supporting all Health, Safety, and Environment (HSE) goals.
Additional Preferences:
Certification from the American Society for Quality (ASQ).
Experience with Computer System Quality Assurance (CSQA).
Previous involvement with manufacturing equipment preparation, formulation, filling, visual inspection, device assembly, packaging, utilities, facilities, maintenance, and warehouse management.
Familiarity with Manufacturing Execution Systems (MES).
Prior experience with KNEAT or similar electronic validation software.
Technical writing experience.
Aptitude for training and mentoring others.
Additional Information:
Ability to work onsite for 8-12 hour shifts (remote work not available).
Willingness to travel 10-25% or potentially relocate during the project phase to support facility design and staffing.
Availability for overtime work as required.
Our organization and its subsidiaries are committed to fostering inclusivity and providing equal opportunities for individuals with disabilities. If you require accommodations to apply for positions, please contact Human Resources for assistance.
We are an Equal Employment Opportunity/Affirmative Action Employer and do not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.
Our Employee Resource Groups (ERGs) offer robust support networks and help develop talented individuals for future leadership roles. Learn more about all of our groups.
Employment Type: Full-Time
Salary: $ 40,000.00 Per Year
