Quality Assurance Operational Support Specialist

1 week ago

Lebanon, Indiana, United States BioSpace, Inc. Full time
Job Details

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We are headquartered in Indianapolis, Indiana, and our employees work together to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.

Organization Overview:

Lilly is constructing a cutting-edge facility for the manufacture of new modalities, including Gene Therapy. This facility will be Lilly's most technically advanced manufacturing site, focused on delivering the next wave of innovative products. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance.

Job Responsibilities:
  • Provide leadership, teamwork, and quality and regulatory knowledge and oversight to guide the design, verification, and startup of manufacturing areas at Lilly's new Lebanon, Indiana site.
  • Ensure GMP compliance in the design, delivery, verification, qualification, and start-up of the facility to ensure regulatory approval.
  • Act as a cGMP liaison, working with Global Facility Delivery and Lilly project staff to complete the detailed design of assigned areas employing QbD and QRM principles and ensuring the integration of Global Quality System requirements into the design.
  • Consult with Network and Global quality groups as required to ensure a consistent and compliant approach is executed during the project and startup phase.
  • Participate in required 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 as well as project and 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 site organization in building technical capability, for a diverse cross-functional staff in Quality, the project team, and area process teams, 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.

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