Senior Quality Control Laboratory Specialist (Instrumentation & Equipment)
A leading biopharmaceutical manufacturer is seeking a Senior QC Specialist to oversee the procurement, qualification, calibration, and lifecycle management of analytical laboratory equipment. Reporting to the QC Equipment Lead, this role is responsible for ensuring full equipment compliance and operational readiness across routine drug substance and drug product testing laboratories.
Key Responsibilities
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Lifecycle & Maintenance Management: Lead calibration, preventative maintenance scheduling, performance trending, and complete lifecycle management for all laboratory equipment.
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Qualification & Verification: Review and approve equipment qualification protocols, calibration records, repair logs, and associated documentation, ensuring parameters align with intended analytical use.
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Cross-Functional Collaboration: Partner with QC, Quality Assurance, and Computer System Validation (CSV) teams to execute qualifications for new equipment, while liaising with external vendors and global site networks.
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Compliance & Data Integrity: Ensure all equipment processes conform to corporate guidelines, GMP standards, and relevant regulatory requirements, including 21 CFR Part 11 and EU Annex 11.
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Investigations & Troubleshooting: Direct equipment-related deviation investigations, out-of-calibration events, and complex technical troubleshooting.
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Process Standardisation: Contribute to the authoring, establishment, and continuous improvement of site procedures related to laboratory equipment.
Candidate Qualifications & Requirements
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Education: Bachelor of Science (B.Sc.) or higher in a relevant scientific discipline.
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Experience: Minimum of 3 years' experience in a GMP laboratory setting, with at least 1 year directly focused on equipment qualification.
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Technical Expertise: Hands-on experience with analytical platforms such as HPLC/UPLC, CE, cIEF, SDS-PAGE, Surface Plasmon Resonance (e.g., Biacore), sub-visible particle analysis, Karl Fischer, and automated liquid handlers.
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Core Skills: Strong background in Data Integrity regulations, project planning, and protein biochemistry fundamentals. Technology transfer experience is preferred.
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Soft Skills: Exceptional communication, time management, and organizational abilities, with a demonstrated capacity to prioritize multiple projects and lead collaboratively within a team-based environment.
