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
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 & Qualifications:
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Quality Professional with Validations and Commissioning & Qualifications of manufacturing equipment and laboratory bench equipment experience (IOQ, PQ, Functional Test).
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Technical Writing
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Quality Systems (Deviations, Change Control) and Maintenance (PM, Work Orders, Job Plans review and approval) knowledge.
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Technical Documents review and approval (Reports, Technical reports, Procedures, Forms) of process and cleaning validation.
Functions:
- Review and approve product MPs.
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Approve process validation protocols and reports for manufacturing processes.
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Request Quality on incident triage team.
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Approve Environmental Characterization reports.
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Release of sanitary utility systems.
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Approve planned incidents.
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Represent QA on NPI team.
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Perform investigations and audits.
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Own site quality program procedures.
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Designee for QA manager on local CCRB.
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Review Risk Assessments.
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Support Automation activities.
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Support facilities and environmental programs.
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Review and approve Work Orders.
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Approve NC investigations and CAPA records.
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Approve change controls.
Education
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Doctorate OR Masters + 2 years of directly related experience OR Bachelors + 4 years of directly related experience OR Associates + 8 years of directly related experience OR High school/GED + 10 years of directly related experience.
