Analytical Op&qc Lab Scientist
Vor 4 Tagen
Work Your Magic with us
Ready to explore, break barriers, and discover more? We know you’ve got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
Work Your Magic with us
Ready to explore, break barriers, and discover more? We know you’ve got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
**Your role**:
Reporting to the “Analytical Operations & Quality Control Lab Manager” in the Global Analytical Development organization, this expert role represents an opportunity to work in a team of highly empowered employees and significantly contribute to high-tech GMP analytical laboratories via direct responsibilities in ensuring stability activities are compliant to regulatory and Merck requirements, contributing to their continuous improvement, supporting investigations and reporting, to ensure the delivery of our specialty innovator Biotech pipeline to patients. This position will also be responsible for coordinating activities linked to qualification of QC robotic platform being SPOC for platform automation activities interacting internally and externally with related stakeholders and partners. In addition, this position also represents an opportunity to have the leading role as super user for laboratory computerized systems and their deployment.
**Your key responsibilities in this role are:
- Support the investigations linked to stability studies, and proposes improvements as needed.
- Follow CMC programs as Analytical Expert, collaborating with project managers and taking care of required related tasks for the team.
- Manage, investigate, and close events and deviations, non-conformities, investigations, change controls and CAPAs related to stability studies.
- Support preparation of audits and interact directly with internal HCQ auditors and external regulatory agencies.
- Directly interact with our business partners on a regular basis, including analytical development, process and quality stakeholders and testing laboratories in the network.
- Acts as SPOC for pre-qualification and qualification steps of QC robotic platform working in a cross functional set up with internal and external automation experts. Specific technical knowledge on Tecan platforms is a plus.
- Acts as Business Owner for assigned QC equipment and computerized systems. Accountable to ensure that a computer system is fit for intended use in accordance with business requirements and applicable procedures throughout the system lifecycle. May act as a backup for other business owners within the QC team.
- Super user of laboratory computerized systems. Authors instrument/system operating procedures. Is accountable for verification of custom calculation setup in QC software and used for analytical testing purposes.
- Authors, reviews and approves validation documents as SME and may also do so as delegate of QC Management.
- Additional responsibilities include performing super user activities for the laboratory computerized systems, representing QC in cross-functional meetings (e.g. multi sites systems introduction/enhancement project) and participating in internal and external audits as Subject Matter Expert (SM
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