JOB DESCRIPTION

Job Summary: The Deviation Specialist is responsible for identifying, documenting, investigating, and resolving deviations from standard procedures, protocols, or regulatory requirements. This role ensures that all deviations are managed in compliance with company policies and industry regulations, and that corrective and preventive actions (CAPAs) are implemented effectively.

QUALIFICATIONS:

• Preferred: Bachelor’s degree in a relevant field such as Life Sciences, Engineering, or Quality Management.
• 2 years of experience in quality assurance, deviation management, or a related role in [industry, e.g., pharmaceuticals, manufacturing, etc.].
• Knowledge of regulatory requirements (e.g., FDA, EMA, ISO) and industry standards.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Proficiency in quality management systems (QMS) and relevant software tools.

PREFERRED QUALIFICATIONS:

• Certification in Quality Management (e.g., Six Sigma, ASQ).
• Experience with electronic documentation systems.
• Familiarity with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).