QUALITY ASSURANCE SPECIALIST

Job Description

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, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

Responsibilities:

Experince in: 

Utility Systems Sampling

• Environmental Monitoring (EM)
• Compressed Gases
• Purified Water
• Steam

Sampling Collection & Environmental Monitoring

Perform sample collection and quality monitoring oversight of PR05 Utilities Systems (e.g., water systems, steam, compressed gases) and the Environmental Monitoring Program (e.g., room air – viable and non-viable, contact plates).

Ensure timely sample collections in accordance with the applicable sampling plan or protocol and in compliance with procedural requirements.

Support QA oversight of Site Utilities Systems and Environmental Monitoring results.

Coordinate with impacted areas including the laboratory, utilities, and manufacturing operations.

Ensure appropriate and correct use of applicable equipment for sample collection and delivery.

Apply and assure appropriate aseptic techniques during all sampling activities.

Ensure timely approval and reporting of applicable sampling results.

Maintain appropriate documentation in compliance with Good Documentation Practices (GDP) and data integrity requirements.

Quality Oversight & Compliance

Provide Quality Assurance oversight to GMP manufacturing operations.

Adhere to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP).

Serve as a reviewer of GMP and quality-related SOPs, as applicable.

Provide QA assistance and feedback to utilities and operational staff.

Inspection Readiness & Continuous Improvement

Support the execution of inspection readiness activities, including participation in self-inspection activities when required.

Maintain quality systems and proactively suggest process improvements.

Escalate quality issues to the site-based process team in a timely manner.

Qualifications Requirements/Knowledge/Education/Skills:

Bachelor’s Degree (minimum) in a science, engineering, or pharmaceutical-related field.

One (1) to three (3) years of experience in a GMP- and FDA-regulated environment in roles such as Quality Assurance, Quality Control Laboratory, Manufacturing, or Technical Services.

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.