Deviations Owner: Quality & CAPA Lead

Mentor Technical Group; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Mentor Technical Group seeks an experienced Deviations Specialist to own and drive deviation investigations in FDA-regulated environments. You will document investigations, determine root cause, and implement CAPA with cross-functional teams to ensure compliance and timely closure.

The role requires a bachelor’s in life sciences or engineering and 5–10 years in deviation management, QA, or compliance, with aseptic or sterile manufacturing exposure and strong GMP knowledge.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Pharmaceutical Sciences, or related field.
• 5-10 years' experience in deviation management, QA, or compliance in FDA-regulated environments.
• Experience in aseptic/sterile manufacturing environments is required.
• Strong GMP knowledge and understanding of FDA regulations.
• English proficiency; additional languages a plus.

Responsibilities

• Own deviations: documentation, investigation, and resolution per FDA/internal standards.
• Coordinate with production, QA/QC, and project teams to evaluate deviations and implement CAPA.
• Maintain records of deviations, investigations, approvals and follow-up.
• Monitor deviation trends and provide reports for continuous improvement.
• Communicate status and regulatory impact to stakeholders.
• Support audits/inspections with deviation management evidence.
• Help develop and optimize deviation management processes and SOPs.

Skills

Deviation mgmt

Quality assurance

GMP knowledge

CAPA experience

eQMS

Root cause analysis

Education

Bachelor's in Life Sciences or related

Tools

eQMS

Deviation tracking

Job description

Mentor Technical Group seeks an experienced Deviations Specialist to own and drive deviation investigations in FDA-regulated environments. You will document investigations, determine root cause, and implement CAPA with cross-functional teams to ensure compliance and timely closure.

The role requires a bachelor’s in life sciences or engineering and 5–10 years in deviation management, QA, or compliance, with aseptic or sterile manufacturing exposure and strong GMP knowledge.