Team Member - Quality Control
Core
Ensure compliance with GLP, GDP, and GMP; manage calibration, standards, and equipment lifecycle; investigate quality deviations; and mentor analysts on analytical techniques.
Role type
Senior Quality Control Team Member (Laboratory Operations)
Builds
Compliant pharmaceutical products and analytical data
Domain
Pharmaceutical manufacturing and quality assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GLP/GDP/GMP compliance, analytical instrument calibration, reference standard management, CAPA implementation, audit participation, Lean Daily Management, HPLC/UPLC/GC chromatography, LIMS/SAP system proficiency, SOP adherence, change control management
Preferred skills
Mentoring analysts, continuous improvement initiatives, cross-functional collaboration
Technologies
SAP, LIMS, Empower, DocHub, iSLATE
Responsibilities
Plan and execute instrument calibration; manage procurement and qualification of reference standards; investigate quality notifications and deviations; conduct Lean Daily Management meetings; participate in internal and external audits; train and qualify analysts on analytical procedures.
Seniority
Senior, hands-on IC
