Analytics Quality Assurance Specialist
Vor 5 Tagen
At Lonza, we are committed to excellence in life sciences. As a QA Analytics Raw Data Reviewer, you will play a crucial role in ensuring the quality and integrity of our raw data.
About the RoleThis is an exciting opportunity for a skilled professional to join our team and contribute to the success of our organization. As a QA Specialist for Analytics, you will be responsible for performing raw data review for Drug substances and drug products.
You will work closely with our QC team to ensure that all raw data meets the required standards and complies with Lonza's policies and procedures.
The key responsibilities of this role include:
- Control of QC raw data (drug product and Lonza GMP sales product)
- Planning and setting of deadlines together with QC
- Organization of meetings, if necessary
- Triggering and processing of deviations in this context
- Creating new checklists for raw data verification and updating existing ones
- Ensuring communication with the responsible QA and QC employees
- Checking QC raw data (without release in LIMS)
- Release of LIMS calculations in DMS (Documentation Management System)
To succeed in this role, you will need to have:
- A Bachelor's degree in chemistry, biotechnology, life science or related field
- 3 to 5 years of experience in the pharmaceutical industry, preferably in a QC or QA function
- Founded analytical expertise
- Strong background in cGMP regulations
- Solution-oriented and strongly team-minded
- Ability to oversee project execution to identify non-compliance from procedures
- Excellent verbal and written communication in German and English
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