Pharma-Bio Serv, a global consulting firm headquartered in Puerto Rico, has been dedicated exclusively to providing services to the largest biotechnology & bio-engineering companies within the regulated industry for more than 30 years. Since our inception, our services have resulted in a project experience level and personnel resource base ranking among the highest worldwide.

Currently, one of our clients is looking to hire a Specialist QA to provide services in the East Region of Puerto Rico.

Requirements:

Bachelor’s degree in Science/ Engineering and 4 years of experience in Quality Systems such as Deviations, Non-conformities, CAPA, Change Control and data integrity concepts.
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
Strong communication (both written and oral), facilitation and presentation skills.
Fully Bilingual in English and Spanish- Required

Job Types: Full-time, Contract

Experience:

New Product Introduction: 4 years (Required)
Validation: 4 years (Preferred)
Document review: 4 years (Required)

Language:

Spanish and English (Required)

Work Location: In person

Pharma-Bio Serv

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Quality Specialist