Job Description
The Quality Assurance Associate III - Integrated Downstream Quality Operations is a role within the Quality Department at the new Large-Scale Manufacturing facility located at the Solothurn/Switzerland site. This position focuses on Quality Operations and Quality Engineering activities for downstream manufacturing and equipment, ensuring the safety, efficacy, and purity of products manufactured.
About the Role:
This Associate III is part of the team responsible for executing QA activities related to downstream operations, GMP manufacturing, and downstream equipment. The successful candidate will review and approve GMP Engineering and Manufacturing documents during project and operational phases of the site. They will also partner with various teams to manage deviations and investigations, ensuring adherence to internal procedures.
Key Responsibilities:
* Execute QA activities for downstream operations, GMP manufacturing, and downstream equipment.
* Review and approve GMP Engineering and Manufacturing documents.
* Partner with cross-functional teams during deviation management and investigations.
* Participate in monitoring and release activities for Column Packing / Unpacking and Chromatography Review.
* Ensure adherence to internal procedures during downstream manufacturing operations or for equipment controls and releases.
* Take part in the Quality On-Call duty rotation.
Requirements:
* Bachelor's degree in relevant field (Chemical Engineering, Bioengineering, Biotechnology, etc.) with at least 5 years of experience in pharmaceutical or biotech manufacturing environment.
* Master's degree in relevant field with at least 3 successful years of experience in pharmaceutical or biotech manufacturing environment.
* Experience with Quality Assurance, Equipment Qualification, Downstream Process is preferred.
* Demonstrated ability to work autonomously with cross-functional team members.
* Strong presentation and organizational skills.
* Excellent writing and problem-solving skills.
* English language proficiency (B1 level).