Deviations Owner

Mentor Technical Group; Juncos (PR); On-site; USD 80,000 - 100,000; Full time

Job summary

Mentor Technical Group (MTG) seeks a qualified candidate to own deviations and ensure compliance in FDA-regulated environments. The role requires at least 5-10 years of experience in quality assurance and a bachelor’s degree in a related field.

The position involves monitoring deviation trends, ensuring proper documentation, and supporting audits. Candidates should have strong communication and analytical skills, specifically with experience in aseptic processes and deviation tracking systems.

Qualifications

• 5-10 years’ experience in deviation management, quality assurance, or compliance in FDA-regulated environments.
• Previous experience in aseptic processes or sterile manufacturing environments.
• Strong understanding of GMP, FDA regulations, and quality systems.
• Proficiency in English; additional language skills are a plus.

Responsibilities

• Serve as the primary owner for deviations, ensuring proper documentation and resolution.
• Coordinate with teams to evaluate deviations and implement corrective actions.
• Maintain accurate records of deviations and investigations.
• Monitor deviation trends and provide management reports.
• Ensure timely communication of deviation status to stakeholders.
• Support audits by providing evidence of compliance.
• Collaborate in the development of deviation management processes.

Skills

Deviations management

Quality assurance

Analytical skills

Communication skills

Problem-solving skills

Education

Bachelor’s degree in Life Sciences, Engineering, Pharmaceutical Sciences, or related field

Tools

Deviation tracking systems

eQMS

Job description

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

Responsibilities

• Serve as the primary owner for deviations, ensuring proper documentation, investigation, and resolution in compliance with FDA and internal quality standards.

• Coordinate with production, QA/QC, and project teams to evaluate deviations, determine root cause, and implement corrective and preventive actions (CAPA).

• Maintain accurate records of deviations, investigations, approvals, and follow-up activities.

• Monitor deviation trends and provide reports to management to support continuous improvement initiatives.

• Ensure timely communication of deviation status and regulatory impact to relevant stakeholders.

• Support audits and inspections by providing evidence of deviation management and compliance.

• Collaborate in the development and optimization of deviation management processes and SOPs.

Qualifications / Requirements / Knowledge / Education / Skills

• Bachelor’s degree in Life Sciences, Engineering, Pharmaceutical Sciences, or a related field.

• Minimum of 5–10 years’ experience in deviation management, quality assurance, or compliance in FDA-regulated environments.

• Previous experience working in aseptic processes or sterile manufacturing environments is required.

• Strong understanding of GMP, FDA regulations, and quality systems.

• Proficiency in English; additional language skills are a plus.

• Experience with deviation tracking systems, CAPA management, and electronic quality management systems (eQMS).

• Excellent analytical, organizational, and problem-solving skills.

• Strong communication skills and ability to collaborate effectively across teams.

Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.

Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.