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:
- Experience in Quality and Compliance, regulatory audits, validation, characterization, automation validation reports.
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Review and approve deviations, critical utilities and environmental monitoring trend reports.
Functions:
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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
- Massters + 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.
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Preferred: Bachelors in sciences with concentration in any science discipline such as Engineering, Biology, Chemistry, Physis, Computer, etc. More than 10 years in a biopharmaceutical industry with over 5 years in Quality, as a minimum.
