Specialist QA

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 :   Review and approve product MPs.

Approve process validation protocols and reports for manufacturing processes.

Request Quality on incident triage team.

Approve Environmental Characterization reports.

Release of sanitary utility systems.

Approve planned incidents.

Represent QA on NPI team.

Lead investigations.

Lead site audits.

Own site quality program procedures.

Designee for QA manager on local CCRB.

Review Risk Assessments.

Support Automation activities.

Support facilities and environmental programs.

Review and approve Work Orders.

Review and approve EMS / BMS alarms.

Approve NC investigations and CAPA records.

Approve change controls.

Provide lot disposition and authorize lots for shipment.

Education : Ph.D OR MS + 2 years of directly related experience OR BS + 4 years of directly related experience OR Associates + 8 years of directly related experience OR High school / GED + 10 years of directly related experience.

Life Sciences or Engineering Skills :   Experience performing Quality Oversight Supporting Supply Chain & Incoming operations experience 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.

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