Quality Assurance Operational Support Specialist

3 days ago


Lebanon, Pennsylvania, United States Lilly Full time
Job Title: Quality Assurance Operational Support

Lilly is seeking a highly skilled Quality Assurance Operational Support professional to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the quality and compliance of our pharmaceutical manufacturing processes.

Responsibilities:
  • Provide quality oversight for the verification and qualification of manufacturing equipment and facilities.
  • Act as a cGMP liaison, working with Global Facility Delivery and Lilly project staff to complete the detailed design of assigned areas.
  • Consult with Network and Global quality groups to ensure consistent and compliant approach is executed during the project and startup phase.
  • Provide technical and quality review and approval of project documents to ensure compliance with Lilly Global Quality Standards.
  • Support the site organization in building technical capability, for a diverse cross-functional staff in Quality, the project team, and area process teams.
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.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.



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