Team Member - Quality Control(LST)

Roles & Responsibilities

• Ensure compliance with Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP).
• 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.
• Ensure availability and adherence to approved SOPs, Specifications, STPs, GTPs, and laboratory procedures.
• Participate in internal and external audits, inspections, and self-inspection programs.
• Manage HPLC, UPLC, GC column compliance and chromatographic activities in Empower.
• Collaborate with cross-functional teams to support product releases and resolve analytical issues.
• Ensure laboratory housekeeping, equipment readiness
• Utilize systems such as LIMS, SAP, DocHub, iSLATE, and Empower as per assigned roles and responsibilities.

Function: Other
Experience Level: Mid-Senior Level