
Quality Assurance Specialist
2 weeks ago
We are seeking a skilled Quality Assurance Specialist to join our global Laboratory Execution Systems Team.
This is a hybrid role that requires experience in either Engineering, IT, R&D or Quality to ensure compliance and perform quality management activities related to GxP qualification/validation and change management.
You will work closely with the QC Project team to analyze requirements and configure software as required.
The key responsibilities of this role include:
- Setting up QC lab systems at sites with GMP/GXP experience in system qualification.
- Creating Standard Operating Procedures (SOPs), Work Instructions (WI), system administration manuals, and validation documents.
- Creating users in the QC LES (Lab Execution) system and setting up administration during deployment phase.
- Gathering and analyzing IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) requirements to support the Validation team.
- Building a dataset and data model to meet user requirements in sites.
- Installing and settling support systems for laboratories, including atomic absorption systems, Gas Chromatography-Mass Spectrometry (GC-MS), time-of-flight mass spectrometry (Maldi TOF), Microsequencer, and Titrator.
- Performing other activities related to the Lab Execution System (LES) supporting new sites and related projects.
In this role, you will have the opportunity to utilize your skills and experience to drive quality and compliance in our laboratory execution systems. If you are passionate about quality assurance and have a strong background in Engineering, IT, R&D or Quality, we encourage you to apply for this exciting opportunity.
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