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Junior Quality Assurance Specialist

2 months ago

Concord NC, United States Lilly Full time

We are a leading organization in the healthcare sector, dedicated to discovering and delivering transformative medicines to those in need. Our global workforce is committed to enhancing disease management and contributing to our communities through philanthropy and volunteer initiatives.

The Junior Quality Assurance Specialist plays a crucial role in demonstrating leadership, collaboration, and expertise in quality and regulatory standards. This position is pivotal in providing guidance and consultation during the design, verification, and initiation of manufacturing operations at our new facility.

This role is essential for ensuring compliance with Good Manufacturing Practices (GMP) throughout the design, execution, verification, and qualification phases, ultimately securing regulatory approval for the site.

As the project evolves, this position will transition to a site-based team, focusing on one of the following manufacturing areas:

  • Device Assembly and Packaging Manufacturing

Key Responsibilities:

  • Act as a liaison for cGMP practices, collaborating with global teams to finalize the detailed design of assigned areas while integrating quality system requirements.
  • Consult with network and global quality groups to ensure a consistent and compliant approach during project execution.
  • Conduct technical and quality reviews of project documentation to ensure adherence to global quality standards.
  • Oversee the verification and qualification processes for manufacturing facilities, including the review of testing protocols and resolution of discrepancies.
  • Collaborate with site quality leadership to shape the vision and strategy for quality operations across manufacturing areas.
  • Support the development of technical capabilities within a diverse cross-functional team, including mentoring and training new staff.
  • Promote a strong quality culture by fostering open communication and teamwork.
  • Lead initiatives to ensure inspection readiness and support self-inspections.
  • Address compliance issues by escalating them to the appropriate management levels.
  • Maintain a safe working environment and uphold all health, safety, and environmental goals.

Qualifications:

  • Minimum of 3 years of experience in quality assurance within pharmaceutical manufacturing.
  • Bachelor's degree or equivalent in a scientific discipline.
  • Experience with Commissioning and Qualification (C&Q) and Validation oversight, including automation and computer systems validation.
  • Familiarity with regulations in pharmaceutical manufacturing across various regions.
  • Ability to work independently as a Subject Matter Expert (SME) with minimal supervision.
  • Proficiency in computer systems, including Microsoft Office and quality management software.
  • Willingness to work onsite in shifts and overtime as necessary.

We are committed to providing equal employment opportunities and fostering an inclusive environment for all individuals, including those with disabilities.

Our employee resource groups offer robust support networks, helping to cultivate talent for future leadership roles.