Specialist QA - Juncos - Administrative shift-34374

Job Description

• 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 substances / 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.

Requirements

Doctorate OR Masters + 2 years of directly related experience

Alternatively, Bachelors + 4 years of directly related experience

Alternatively, Associates + 8 years of directly related experience

Educational background in Life Science and / or Engineering.