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Quality Assurance Operational Support Specialist

2 months ago

Lebanon, Pennsylvania, United States Lilly Full time
About the Role

We are seeking a highly skilled Quality Assurance Operational Support Specialist to join our team at Lilly. As a key member of our Quality Assurance team, you will play a critical role in ensuring the design, verification, and startup of our manufacturing areas meet the highest standards of quality and regulatory compliance.

Key Responsibilities
  • Provide leadership and guidance on cGMP practices, including good documentation practices, data integrity, and regulatory compliance.
  • Act as a cGMP liaison, working with Global Facility Delivery and Lilly project staff to complete the detailed design of assigned areas, ensuring the integration of Global Quality System requirements into the design.
  • Consult with Network and Global quality groups to ensure a consistent and compliant approach is executed during the project and startup phase.
  • Participate in design reviews and final design qualification activities.
  • Provide technical and quality review and approval of project documents to ensure compliance with Lilly Global Quality Standards and project/local quality procedures.
  • Provide quality oversight for the verification and qualification of manufacturing equipment and facilities, including review of test cases, test execution, discrepancy resolution, etc.
  • Support the development of the vision and strategy for the overall site quality operation and cross-functional support with focus on the Manufacturing areas.
  • Support the site organization in building technical capability, including mentoring and training of new Quality and other project staff.
  • 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 in GQA.
  • Lead project initiatives needed in support of the project and Quality function.
  • Resolve or escalate any compliance issues to the project, site, and Quality Management.
Requirements
  • Bachelor's degree in a relevant field (preference for scientific or engineering field).
  • 3+ years working in the pharmaceutical manufacturing industry in Quality Assurance roles.
  • Previous experience with C&Q / Verification and Validation oversight, including automation and computer systems validation.
Preferred Qualifications
  • Demonstrated knowledge and use of US, EU, Japan, and other regulations in the area of pharmaceutical manufacturing.
  • ASQ Certified.
  • Computer System Quality Assurance experience.
  • Previous facility or area start-up experience.
  • Previous experience with gene therapy drug substance processes, such as equipment prep, virus prep/banking, inoculation, purification, and/or drug product manufacturing processes, such as formulation, filling/visual inspection, and packaging.
  • Previous experience with lab equipment delivery and qualification.
  • Previous experience with management of utilities, facilities, maintenance, and warehouse logistics.
  • Previous experience with Manufacturing Execution Systems.
  • Previous use of KNEAT – or other electronic validation software.
  • Demonstrated ability to communicate with and influence cross-functional teams, including good oral and written communication skills.
  • Demonstrated strong problem-solving and decision-making skills.
  • Previous technical writing experience.
  • Technical aptitude and ability to train and mentor others.