Analytical Technology & Operations Specialist
Core
Support the technical and operational lifecycle of QC laboratories for new builds, relocations, and technology implementation, ensuring compliance and minimizing testing disruption.
Role type
Quality Control Laboratory Operations Specialist
Builds
Highly automated drug substance manufacturing facility QC labs
Domain
Pharmaceutical manufacturing / Quality Control
Required skills
Laboratory workflow design, Equipment qualification (IQ/OQ/PQ), Computerized system validation, SOP development, Data integrity assessment, LIMS configuration, Change control management, Sample flow documentation, Instrument installation coordination, Regulatory compliance (cGMP, ALCOA+)
Preferred skills
Laboratory system integration (CDS, LIMS, instrument interfacing), Laboratory build or relocation project experience
Technologies
LIMS, Lab bus systems, Networked data acquisition
Responsibilities
Document requirements for lab builds and technology implementation, Execute qualification protocols and acceptance testing, Draft and revise SOPs for lab operations, Coordinate instrument delivery and FAT/SAT activities, Support data integrity risk assessments, Maintain integration documentation for lab systems, Provide post-handover support to QC testing teams
Seniority
Associate (0-2 years) to Senior (5+ years)