Deviation Investigator

Job Description

Job Summary:

• The Deviation Investigator is responsible for identifying, documenting, and investigating deviations from standard operating procedures, quality standards, or regulatory guidelines.
• This role requires collaboration with cross-functional teams to develop and implement corrective and preventive actions.
• The position also involves maintaining accurate records, ensuring compliance with company policies, and participating in continuous improvement initiatives.

Duties and Responsibilities:

• Identify and document deviations from standard operating procedures (SOPs), quality standards, or regulatory guidelines.
• Conduct thorough investigations to determine the root cause of deviations.
• Collaborate with cross-functional teams to develop and implement corrective and preventive actions (CAPAs).
• Maintain accurate and detailed records of all deviations, investigations, and CAPAs.
• Prepare and present deviation reports to management and regulatory authorities as required.
• Ensure documentation is completed in accordance with Good Documentation Practices (GDP).
• Ensure all deviations are managed in compliance with company policies, industry standards, and regulatory requirements.
• Participate in internal and external audits and inspections, providing necessary documentation and information related to deviations.
• Analyze deviation trends and provide insights for continuous improvement initiatives.
• Participate in training programs to enhance knowledge and skills related to deviation management and quality assurance.

Required Experience:

• Experience in a regulated industry, cGMP environment, or deviation management.

Preferred Education and Experience:

• Associate or bachelor’s degree in a relevant field such as Life Sciences, Engineering, Medical, or Quality Management with 2 years of related experience.
• Preferred experience in Biologics, Aseptic, Filling Isolators, Six Sigma Certification, Electronic documentation systems.

Knowledge, Skills and Abilities:

• Strong attention to detail, technical writing, analytical, and problem-solving skills.
• Knowledge of regulatory requirements and standards.
• Intermediate to advanced skills in Microsoft Suite (Word, Excel, PowerPoint).
• Excellent communication and interpersonal skills.
• Familiarity with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).