Join a vibrant team at the forefront of the biopharmaceutical industry, where your skills will contribute to high-quality manufacturing processes and compliance standards. This role offers the opportunity to be a key player in ensuring the success of new commercial biological drug substance operations.

We are seeking a dedicated USP Quality Specialist who will take ownership of upstream quality assurance activities. If you are passionate about quality processes, regulatory compliance, and driving continuous improvement, this role is an excellent match for your expertise.

• You oversee quality assurance activities related to upstream processes in production.
• You participate in Quality Operational Team meetings, sharing valuable production knowledge.
• You ensure compliance with all GMP documentation through diligent review and approval.
• You manage deviations, CAPA, and change control processes effectively.
• You provide training and coaching to team members, enhancing their quality and process knowledge.
• You assist in the site audit and inspection readiness programs, ensuring compliance with regulatory standards.
• You engage with stakeholders to promote alignment with production objectives.