Quality Assurance Specialist

2 months ago


Durham, North Carolina, United States Lilly Full time
Job Title: Quality Assurance Specialist

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 products.

Job Summary:

The Quality Assurance Specialist will be responsible for reviewing batch records, performing final batch disposition, and ensuring compliance with Good Manufacturing Practices (GMP) standards. This role requires strong analytical and problem-solving skills, as well as excellent communication and leadership abilities.

Responsibilities:
  • Review batch records and perform final batch disposition to ensure high-quality products are released to the market.
  • Lead and mentor site personnel on quality matters associated with batch disposition.
  • Provide guidance on operational areas to ensure robust Quality Systems and GMP compliance.
  • Participate in self-led inspections and provide support during internal/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.
  • Strong oral and written communication skills.
  • Interpersonal skills and ability to work as a team.
  • 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles.



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