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Analytical Operations and QC Compliance Specialist - BDC
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.
Reporting to the “Analytical Operations & Quality Control Unit Head” in the Global Analytical Development organization, this role represents an opportunity to work in a team of highly empowered employees and significantly contribute to the startup of high-tech GMP analytical laboratories, by executing the plan for procedural landscape for the analytical GMP laboratories and supporting the commissioning, qualification and validation for analytical systems. Once functional, you will be the “QC quality champion on the floor” - this role will give you direct responsibilities in ensuring QC processes 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.
Your key responsibilities in this role are:
- Contribute to the startup of high-tech GMP analytical laboratories by supporting procedure/document writing and analytical equipment for at least one of the following areas (e.g., for ELISA, PCR systems, spectrophotometers and readers, biosensors, microbiology testing and/or basic laboratory equipment) qualification processes and services
- Support the QC team in their daily operations as an expert of the compliance aspect for QC capitalizing on organizational and operational flexibility
- Contribute to the data review process according to the established quality requirements
- Manage, investigate and close events and deviations, non-conformances, investigations, change controls and CAPAs, period reviews in support of SMEs in QC
- Drive, monitor and assure delivery of the Data Integrity Plan, including DI risk-analysis assessment and action plan, and periodically report status/progress to leadership team. Support Escalation
- Continuously improve data integrity knowledge base and understanding: detect and mitigate DI risks by working with SMEs, identify training needs and deliver training
- Contributes to the assessment of regulatory and pharmacopoeia updates linked to QC activities.
- Support preparation of audits and interact directly with internal HCQ auditors and external regulatory agencies.
Who you are:
- Graduate degree in Chemistry, Pharmacy, Biology, or Biotechnology
- 5+ solid hands-on experience in QC lab
- Experience with Quality Systems such as Deviation, CAPA, Change control
- Thorough understanding and practical application of cGMPs and regulatory requirements (Swiss, FDA, EU,..)
- Excellent investigational skills and problem-solving skills. Ability to interpret complex situations and to articulate recommendations for resolution
- Previous direct experience in audits and interactions with healthcare authorities
- Stability management of DS and DP will be regarded as a plus
- English fluent, French is an asset
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!