Team Member - Quality Control
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Job Description
Roles & Responsibilities
• Ensure compliance with Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP).
• Responsible for the procurement, qualification, and lifecycle management of laboratory instruments, analytical equipment, consumables, reference standards, and critical reagents.
• Manage vendor identification, evaluation, qualification, and performance monitoring to ensure reliable supply and service support.
• Coordinate with Procurement, Quality, and Finance teams for timely purchasing, contract management, and vendor compliance activities.
• Maintain laboratory safety standards and promote a strong safety culture.
• Plan, monitor, and execute scheduled and unscheduled calibration activities for analytical instruments.
• Manage the procurement, qualification, maintenance, and availability of reference standards, working standards, and impurities.
• Coordinate calibration and instrument management activities through SAP and LIMS.
• Ensure compliance, maintenance, and lifecycle management of QC instruments and laboratory equipment.
• Train, mentor, and qualify analysts on analytical techniques and laboratory procedures.
• Review calibration schedules, instrument inventories, and laboratory documentation.
• Conduct Lean Daily Management meetings and support continuous improvement initiatives.
• Investigate quality notifications, incidents, deviations, OOS/OOT results, and implement effective CAPAs.
• Review and support Change Controls, CAPAs, and Quality Management System notifications.
• Participate in internal and external audits, inspections, and self-inspection programs.
Requirements
Function: Other
Experience Level: Mid-Senior Level