Quality Assurance Specialist
Quality Assurance Specialist
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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 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 recibirn consideracin para el empleo sin importar raza color religin sexo orientacin sexual identidad de gnero informacin gentica 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.
Required Experience:
Manager
Employment Type
Full-Time
