Quality Assurance Specialist

Mentor Technical Group (MTG) is seeking a Quality Assurance Specialist to join their team. The ideal candidate will have expertise in Quality Systems, electronic systems, and validation processes, as well as strong communication and leadership skills.

Requirements

• 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

Benefits

• Equal opportunity employer
• 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