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Quality Compliance Specialist
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We are seeking a highly skilled Quality Compliance Specialist to join our team. The successful candidate will be responsible for providing support across various regulatory reporting and inspection activities.
Key Responsibilities- Coordinate and execute regulatory reporting, including networking with internal stakeholders to determine the need and document the decision for regulatory reporting.
- Generate, submit, and maintain documentation following standard procedures.
- Provide information for use in various periodic reviews or metrics.
- Support the coordination of US product recall and withdrawals, including participating in periodic product withdrawal/recall simulations.
- Monitor recall activities of partner organizations globally.
- Bachelor's degree or equivalent experience in a scientific field such as Pharmacy, Chemistry, Engineering, or other biological sciences.
- Minimum of 5 plus years relevant industry experience in areas which may include: technical services, manufacturing operations, quality assurance, quality control, or regulatory affairs.
- Previous auditing experience and broad knowledge of GMPs and quality systems as they apply to pharmaceutical manufacturing and marketing.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. We offer a dynamic and inclusive work environment, with opportunities for professional growth and development.
