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Biotechnology QA Professional

1 week ago

Limerick, Limerick, Ireland Eli Lilly and Company Full time
Position Summary
We are seeking a Senior Associate to join our quality assurance team and ensure the highest standards of product quality and compliance for our computer systems. As a member of our team, you will play a critical role in maintaining the quality and regulatory compliance of our biopharmaceutical products within our next-generation manufacturing facility.

Responsibilities:
- Develop and maintain quality assurance procedures, policies, and systems to ensure consistency across all computer systems areas.
- Conduct routine self-inspections and monitoring assessments (time-on-the-floor) to ensure compliance with cGMP (current Good Manufacturing Practices) and other relevant regulations.
- Collaborate with automation, IT, and production teams to ensure quality throughout the manufacturing process.
- Investigate and address deviations, non-conformities, and CAPA (Corrective and Preventive Actions) to maintain quality.
- Participate in IT and process automation organizations to provide consistency across all computer systems areas.

Requirements:
- Bachelor's degree in Science, Engineering, Quality, or related discipline.
- 3+ years of experience in quality assurance within a biotechnology, pharmaceutical, or medical device manufacturing environment.
- Strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management, and other biopharmaceutical regulatory requirements.
- Excellent problem-solving and analytical skills.
- Detail-oriented with a strong commitment to maintaining high-quality standards.
- Effective communication and teamwork skills.
- Demonstrated initiative – able to work proactively without direct supervision and with a continuous improvement mindset.