Specialist QA 35269

Inteldot • Juncos, PR

20h

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

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.
• 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.

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: No Education Listed