**Job Title:** Quality Assurance Associate III - Integrated Downstream Quality Operations
About the Job:
The Quality Assurance Associate III - Integrated Downstream Quality Operations will be part of the Quality Department at our new Large-Scale Manufacturing facility located at the Solothurn/Switzerland site. This role focuses on Quality Operations and Quality Engineering activities for downstream manufacturing and equipment.
Key Responsibilities:
* Execute QA activities related to downstream operations, GMP manufacturing, and downstream equipment to ensure the safety, efficacy, and purity of products manufactured.
* Review and approve GMP Engineering and Manufacturing documents during project and operational phases of the site, specifically related to procedures, work instructions, CAPAs, deviations, change control, equipment (work orders, P&IDs, qualification protocols, calibration deviations) etc.
* Collaborate with Manufacturing, Manufacturing Sciences, Process Engineering, Automation SMEs 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 release before and during GMP CAPEX and OPEX project (i.e., shutdowns, construction projects) or New product introduction.
* Contribute to Quality On-Call duty rotation for Quality.
* Participate in batch record review and close out in the view of batch release.
Requirements:
* Bachelor's degree in a relevant field such as Chemical Engineering, Bioengineering, Biotechnology, Bioprocessing, Pharmaceutical Sciences, Pharmaceutical Regulations and at least 5 years of experience in pharmaceutical or biotech manufacturing environment.
* Master's degree in a relevant field such as Chemical Engineering, Bioengineering, Biotechnology, Bioprocessing, Pharmaceutical Sciences, Pharmaceutical Regulations and 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.
* Demonstrated writing skills.
* Demonstrated problem-solving skills.
* English - minimum B1 level.