Specialist QA |PR ID 33934

Inteldot has over 14 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.

Job Description:

Under minimal supervision, support Quality Assurance program by performing a variety of key responsibilities in manufacturing, process validation, regulatory compliance, and quality assurance activities. This role requires strong technical expertise, project management skills, and the ability to work cross-functionally in a regulated environment.

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

Requirements:

• Experience in Quality Systems (Deviations, CAPAs, Change Controls) and Equipment, Processes and Facilities Validation
• Experience in Quality Systems management and Validation.
• Knowledge or to be familiar with in PAS-X/MES application, MAXIMO, SAP, LIMS, QMTS and Veeva.
• Available during weekends and holidays as requested

Education & Experience:

• Bachelor’s degree & 5 years of related experience