Specialist Qa 35269

Puerto Rico
Permanent
Full-time

2 days ago

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.Administrative Shift: Available during weekends and holidays as requestedJob 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.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

Job Requirements:

Quality Professional with experience in Quality System and Validations.
Knowledge or to be familiar with in PASx/MES application, MAXIMO, SAP, LIMS, QMTS and Veeva.
Experience in Quality Systems (Deviations, CAPAs, Change Controls) and Equipment, Processes and Facilities Validation.

Education:

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.

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