Specialist QA

10th October, 2024

SUMMARY

Perform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision.

Requirements:

• Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience years of directly related experience (Science or Engineering)
• 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, facility, utility, and equipment 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.