Global Validation/Verification coordinator

The Validation/Verification Coordinator coordinates the implementation of (new or updated) laboratory tests in compliance with applicable regulatory requirements and quality standards. Coordinates and oversees test validation and verification activities, associated documentation, and QA and CAP Director reviews to ensure timely report approval and support successful test implementation.

Responsibilities

Coordinate the implementation of (new or updated) laboratory tests in compliance with applicable regulatory requirements and quality standards; Coordinate and oversee test validation and verification activities, associated documentation, and QA and CAP Director reviews to ensure timely report approval and support successful test implementation; Coordinate global validation or verification of laboratory tests; Align with operational teams and laboratories on required activities and documentation; Define and track validation/verification milestones with relevant stakeholders; Ensure compliance with global validation and verification standards; Complete, review, and approve all documentation, including final signed validation/verification reports

Requirements

Master's degree in Biochemistry/Life Sciences, or a bachelor's degree with relevant experience; Minimum of 5-10 years of (medical) clinical laboratory experience; At least 1-2 years of experience writing clinical laboratory validation/verification reports; Experience in hematology, clinical chemistry and serology, flow cytometry and molecular biology; Prior hands-on experience in method verification/validation; Working knowledge of EP Evaluator or similar statistical software for clinical laboratory validation/verification; Honest, dependable, demonstrated ability to self-manage; Detail oriented, accurate, precise; Strong math skills; Strong organizational skills; Logical thinking, good reasoning ability; Strong communication including verbal, writing, and presentation skills; Dedication to quality, ethics, and customer service; Ability to handle personal stress; Mental and emotional stability and maturity; Motivation to excel; Ability to sit for long periods as per role requirement; Team Lead experience

Nice to have

Familiarity with EP Evaluator specifically is preferred; Team Lead experience