Quality Assurance Specialist

5 days ago


Durham, North Carolina, United States Lilly Full time

We're seeking a highly skilled Quality Assurance 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 quality and safety of our pharmaceutical and device products.

Key Responsibilities:

  • Review and approve batch records to ensure compliance with GMP standards.
  • Perform final batch disposition of raw materials, components, and finished products to ensure high-quality medicine is released to the market.
  • Lead and mentor site personnel on quality matters associated with batch disposition.
  • Provide guidance on quality systems and GMP compliance.
  • Participate in self-led inspections and provide support during internal and external regulatory inspections.
  • Effectively review and approve GMP documents to ensure quality attributes are met.
  • Participate in Six Sigma projects and process improvement initiatives to improve productivity within the Batch Disposition work center.

Requirements:

  • Bachelor's degree in a science or engineering-related field.
  • At least 10 years of experience in QA roles in the pharmaceutical or medical device industry.
  • Previous batch disposition experience supporting device, parenteral, or drug substance products/materials.

Preferred Skills:

  • Proficiency with Manufacturing Execution Systems (MES), Inventory Management Systems (IMS), Laboratory Information Management Systems (LIMS), and Deviation Management Systems (DMS).
  • Demonstrated experience in a GMP facility.
  • Ability to make technical decisions and provide guidance to the site.
  • Demonstrated strong oral and written communication skills.
  • Demonstrated interpersonal skills and ability to work as a team.
  • Demonstrated attention to detail and ability to maintain quality systems.
  • Previous regulatory inspection readiness and inspection execution experience.

About Lilly:

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.

We offer a flexible working environment with the ability to periodically work remotely based on site activities.



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