Quality Assurance Specialist
We are seeking a highly motivated and detail-oriented Biotechnology QA Sr. Associate to join our quality assurance team.
Key Responsibilities:
* Maintain the quality and regulatory compliance of biopharmaceutical products within our next-generation manufacturing facility.
* Develop and maintain quality assurance procedures, policies, and systems.
* Conduct routine self-inspections and monitoring assessments to ensure compliance with cGMP and other relevant regulations.
* Investigate and address deviations, non-conformities, and CAPA to maintain product quality.
* Stay current with industry regulations, guidelines, and best practices.
* Ensure that all products meet regulatory requirements, including documentation and reporting.
Requirements:
* BSc Hons, MSc, or PhD in Pharmacy, Science, Engineering, Quality, or related discipline.
* 5+ years of experience in quality assurance within a biotechnology or pharmaceutical 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.