Quality Assurance (Hybrid)

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

Job summary

Mentor Technical Group seeks a Quality Lead to oversee QA activities for a pharmaceutical maintenance system assessment in Puerto Rico. You will review QMS requirements, audit procedures, and regulatory compliance, guiding cross-functional teams across Engineering, Manufacturing, CQ, and Materials Management.

The role requires strong analytical and communication skills, experience with validation/verification, and bilingual English/Spanish proficiency.

Qualifications

• Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Technology, or a related scientific field.
• Proven experience with validation, qualification, and verification in a pharmaceutical manufacturing environment.
• Strong knowledge of current Good Manufacturing Practices (cGMP) and other regulatory requirements.
• Experience with Change Control processes and regulatory impact assessments, with cross-functional coordination.

Responsibilities

• Lead and coordinate Quality activities associated with the Maintenance System assessment.
• Assess applicable QMS requirements and compliance controls.
• Review maintenance procedures, workflows, and documentation practices.
• Evaluate CMMS use and Work Order documentation from a Quality and Compliance perspective.
• Assess governance, roles, responsibilities, and escalation processes.
• Review Change Management and Engineering Change Management processes.
• Evaluate interfaces between Engineering, Manufacturing, Maintenance, Operations, CQ, Quality, and Materials Management.
• Participate in interviews, process walkthroughs, and documentation reviews.
• Identify compliance gaps, risks, and improvement opportunities.
• Support the development and prioritization of corrective and improvement actions.
• Track identified observations and actions through completion.
• Provide Quality guidance to project stakeholders.
• Support preparation of assessment reports and management presentations.

Skills

Analytical skills

Problem solving

Communication skills

Bilingual English/Spanish

Regulatory knowledge

cGMP knowledge

Education

Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Technology, or a related scientific field

Tools

MS Office

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 ensures 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.

The Quality Lead will be responsible for:

• Lead and coordinate Quality activities associated with the Maintenance System assessment.
• Assess applicable QMS requirements and compliance controls.
• Review maintenance procedures, workflows, and documentation practices.
• Evaluate CMMS use and Work Order documentation from a Quality and Compliance perspective.
• Assess governance, roles, responsibilities, and escalation processes.
• Review Change Management and Engineering Change Management processes.
• Evaluate interfaces between Engineering, Manufacturing, Maintenance, Operations, C&Q, Quality, and Materials Management.
• Participate in interviews, process walkthroughs, and documentation reviews.
• Identify compliance gaps, risks, and improvement opportunities.
• Support the development and prioritization of corrective and improvement actions.
• Track identified observations and actions through completion.
• Provide Quality guidance to project stakeholders.
• Support preparation of assessment reports and management presentations.

Key Responsibilities:

The Quality Lead will serve as the primary Quality point of contact for the assessment and will:

• Coordinate Quality-related assessment activities.
• Ensure consistency in the evaluation of compliance requirements.
• Facilitate communication between Quality and other functional areas.
• Escalate significant compliance risks or concerns.
• Support development of practical and sustainable recommendations.
• Monitor progress against agreed action plans

Qualifications / Requirements / Knowledge / Skills:

• Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Technology, or a related scientific field.
• Proven experience in validation, qualification, and verification within a pharmaceutical manufacturing environment.
• Strong knowledge of current Good Manufacturing Practices (cGMP) and other regulatory requirements.
• Experience with Change Control processes, regulatory impact assessments, and cross-functional coordination.
• Excellent skills in reviewing, auditing, and writing technical documentation.
• Ability to manage multiple projects and prioritize tasks effectively.
• Strong analytical, problem-solving, and communication skills.
• Proficient in MS Office applications (Word, Excel, PowerPoint, etc.).
• Bilingual: fluent in English and Spanish preferred.

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.