Team Member – Analytical QA

Job Summary
This role is for a Quality Assurance Specialist – Analytical Compliance, responsible for ensuring end-to-end adherence to regulatory standards and SOPs in Quality Control (QC) laboratory operations, with a focus on analytical data integrity, investigation management, and documentation oversight.
Roles &

Responsibilities
• You will be responsible for participating in investigations of Quality Management System (QMS) documents such as OOS, OOT, and laboratory deviations, and ensuring timely closures as per SOP timelines.
• You will be responsible for preparing trending reports for OOS, OOT, and laboratory incidents, using analytical insights to support CAPA identification and process improvements.
• You will be responsible for evaluating Change Controls and CAPA action plans, verifying their effectiveness to ensure resolution of root causes and prevention of recurrence.
• You will be responsible for reviewing all analytical data generated in the Quality Control laboratory—including electronic and raw data—ensuring accuracy and compliance with relevant SOPs.
• You will be responsible for reviewing instrument and equipment calibration records and audit trails to confirm reliability, data integrity, and GMP adherence.
• You will be responsible for preparing and reviewing documentation related to stability samples and ensuring that reference standards, impurity standards, working standards, and related records are maintained per applicable procedures.
• You will be responsible for performing and verifying SAP transactions related to laboratory workflows and data entries as outlined in SOPs, ensuring traceability and accuracy.
• You will be responsible for reviewing and approving method validation and method transfer protocols and reports, as well as LIMS master data and control limit updates, ensuring analytical consistency across platforms.