Quality Assurance Specialist
2 days ago
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 medical device products.
Key Responsibilities:
- Review and approve batch records for parenteral manufacture, semi-finished devices, and final packaged products.
- Perform final batch disposition of raw materials, components, active pharmaceutical ingredients, semi-finished and/or finished drug product and combination product batches.
- Lead and mentor site personnel on quality matters associated with batch or batch disposition processes.
- Provide guidance on operational areas to ensure robust Quality Systems and GMP compliance.
- Participate in self-led inspections and/or provide support during internal/external regulatory inspections.
- Effectively review and approve GMP documents to ensure quality attributes are met.
- Participate in Six Sigma projects or process improvement initiatives to improve productivity within the Batch Disposition work center and/or the site.
Requirements:
- Bachelor's degree or equivalent 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 relevant experience in a GMP facility.
- Ability to make technical decisions, provide guidance to the site, and lead others.
- Demonstrated strong oral and written communication skills.
- Demonstrated interpersonal skills and the 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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