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Associate III – Integrated Downstream Quality Operations
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Work with us on a Quality Operations assignment within a large\-scale biopharmaceutical manufacturing environment in Solothurn.
Associate III – Integrated Downstream Quality Operations
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### Job description:
As an **Associate III – Integrated Downstream Quality Operations**, you will support Quality Assurance activities across downstream GMP manufacturing operations and equipment, working closely with Manufacturing, Process Engineering, Manufacturing Sciences and Automation teams.
### About the customer:
* **Location:** Solothurn, Switzerland
* **Workload:** 100%
* **Start:** As soon as possible
* **Until:** with possible extension
* **Department:** Quality Assurance / Integrated Downstream Quality Operations
### Requirements:
* Provide **QA shopfloor oversight** for downstream manufacturing operations
* Review **electronic batch records (eBR), electronic logbooks, LIMS records and samples**
* Review and approve GMP Manufacturing and Engineering documentation
* Manage **minor and major deviations** and support investigations
* Support **CAPAs, change controls and equipment\-related quality activities**
* Provide Quality oversight for **equipment qualification**, work orders, P\&IDs, qualification protocols and calibration deviations
* Support **column packing/unpacking and chromatography review and release**
* Perform Quality oversight of **PLM, CMMS and Kneat** activities
* Participate in **batch record review and close\-out** in preparation for batch release
* Support equipment controls and release during **GMP CAPEX/OPEX projects, shutdowns and new product introductions**
* Participate in the **Quality On\-Call rotation**
* Collaborate cross\-functionally to ensure compliance with applicable GMP and regulatory requirements
### Competences:
* **Bachelor’s degree** in Chemical Engineering, Bioengineering, Biotechnology, Bioprocessing, Pharmaceutical Sciences, Pharmaceutical Regulations or a related field with **at least 6 years of relevant pharmaceutical/biotech manufacturing experience OR****Master’s degree** in a relevant field with **at least 4 years of relevant pharmaceutical/biotech manufacturing experience**
* Experience within a **GMP pharmaceutical or biotechnology manufacturing environment**
* Experience in **Quality Assurance**; exposure to **downstream processing and equipment qualification** is strongly preferred
* Experience with **deviations, investigations and GMP documentation**
* Understanding of downstream manufacturing operations and equipment
* Ability to work autonomously and effectively with cross\-functional teams
* Strong organizational, writing, presentation and problem\-solving skills
![Swisslinx AG]()
* Swisslinx AG
Löwenstrasse 29
8001 Zürich
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