Quality Assurance Specialist at Mentor Technical Group

Juncos, , Puerto Rico -

Full Time

Start Date

Immediate

Expiry Date

09 Apr, 26

Salary

0.0

Posted On

09 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Systems, Deviations, CAPA, Change Control, Electronic Systems, Documentation Platforms, Validation, Risk Assessment, Operational Qualification, Performance Qualification, Communication Skills, Bilingual, Leadership, Negotiation, Regulatory Compliance, Project Management

Industry

Pharmaceutical Manufacturing

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, 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: Expertise in Quality Systems such as Deviations (Non-conformities, CAPA, and Change Control). Hands on experience in electronic systems for instance: Documentation platforms (CDOCS), Maximo, Trackwise, LIMS, electronic batch record (MES) and SAP. Experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements. Validated experience as Quality Contact for sophisticated projects involving new drug substance/products with experience in commissioning and qualifications. Enhanced skills in leading, influencing and negotiating with the ability to interact with regulatory agencies and evaluate compliance issues.+ Strong communication (both written and oral), facilitation and presentation skills. Fully Bilingual in English and Spanish. Qualifications Requirements/Knowledge/Education/Skills: BS in Life Science and/or Engineering. 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.

Responsibilities

The Quality Assurance Specialist will oversee quality systems including deviations, CAPA, and change control. They will also validate GxP applications and serve as a quality contact for complex projects.