Deviation Management Lead — GMP, CAPA & QA

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) 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.