November 4, 2024

Inteldot

FULL TIME

Specialist QA ID33658

Inteldot has over 14 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients Segoe UI in Puerto Rico.
Description:

Perform one or more of the following duties and responsibilities in support of the client Quality Assurance program under minimal supervision.

Responsibilities:

Review and approve product MPs.
Approve process validation protocols and reports for manufacturing processes. - Request Quality on incident triage team.
Approve Environmental Characterization reports.
Release of sanitary utility systems.
Approve planned incidents.
Represent QA on NPI team.
Lead investigations.
Lead site audits.
Own site quality program procedures.
Designee for QA manager on local CCRB.
Review Risk Assessments.
Support Automation activities.
Support facilities and environmental programs.
Review and approve Work Orders.
Review and approve EMS/BMS alarms.
Approve NC investigations and CAPA records.
Approve change controls.
Provide lot disposition and authorize lots for shipment.

Competencies / Skills:

Expertise in Quality Systems such as Deviations (CAPA, and Change Control, Data Integrity Concepts).
Experience in Warehouse and Incoming QC operations
Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.

Education:

Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience