Specialist QA 35271

Inteldot • Juncos, PR

1d • Onsite

About The Position

Inteldot has over 15 years in the life sciences industry, with operations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico. The Specialist QA position, operating under minimal supervision during an administrative shift, supports the Quality Assurance program. This involves performing a variety of key responsibilities in manufacturing, process validation, regulatory compliance, and general quality assurance activities.

Requirements

• Quality Professional with experience in Equipment, Automation and Validation.
• Knowledge or to be familiar with in PASx/MES application, MAXIMO, SAP, and LIMS.
• Experience in Change Control.
• Doctorate or Masters + 2 years of experience, Bachelors + 4 years of experience, Associates + 8 years of experience or High school/GED + 10 years of experience.
• Sciences or Engineering

Responsibilities

• Review and approve product Master Plans (MPs).
• Approve process validation protocols and reports for manufacturing processes.
• Participate in Quality on Incident Triage Team.
• Approve Environmental Characterization reports.
• Release sanitary utility systems.
• Approve planned incidents.
• Represent QA in the New Product Introduction (NPI) team.
• Lead investigations and site audits.
• Own and maintain site quality program procedures.
• Serve as QA Manager designee on local Change Control Review Board (CCRB).
• Review and assess risk evaluations.
• Support automation activities, facilities, and environmental programs.
• Review and approve Work Orders and EMS/BMS alarms.
• Approve non-conformance (NC) investigations and CAPA records.
• Approve change controls

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree