Operations Quality Control Specialist
Vor 5 Tagen
Lonza is a global leader in life sciences operating across three continents. Our success is built on talented people working together to devise innovative solutions that improve lives worldwide. We are seeking a highly skilled Operations Quality Control Specialist to join our team at BioAtrium.
BioAtrium is a rapidly growing organization with a state-of-the-art Biologics Drug Substance facility. As a key member of our team, you will be responsible for ensuring GMP compliant activities on the manufacturing floor and providing real-time oversight and support for colleagues within operations.
Main Responsibilities:- Compliance and Quality: Ensure GMP compliant activities on the manufacturing floor and support operations colleagues in achieving this goal.
- Document Review and Approval: Support in reviewing and approving process-related Change Requests, Deviation, OOS Investigations, CAPAs, and other related documents.
- Contamination Control and Prevention: Contribute to ensuring contamination control and participating in contamination investigations.
- Validation and Qualification Protocols: Ensure on-the-floor execution of validation and qualification protocols.
- Equipment Inspections: Perform regular visual inspections on equipment.
- Error Reporting and Escalation: Escalate any identified material defect or malfunction issues witnessed within the facility.
- GEMBA Participation: Participate in GEMBA and contribute to a collaborative team environment.
- Absolved technical apprenticeship is required; a degree in chemistry/biology/science or a related field is an advantage.
- Professional experience and GMP knowledge within a GMP manufacturing facility is required; experience in a Biologics facility is an advantage.
- Additional experience in a GMP Quality department is an advantage.
- Proficiency in Microsoft Office Suite and eQMS (Trackwise, DMS, and LIMs).
- Excellent English language skills are required; German fluency is an advantage.
- Flexibility to work irregular hours including occasional Saturdays and 5 Sundays a year.
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