Specialist QA 35619
Jornada completa
Inteldot
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:
- E xperienced working in biopharmaveutical industry
- Quality organization supporting deviations, validation reports, qualifications, investigations
- At least 5 years of experienced in a highly regulated environment .
- Technical Writing
- Technical Documents review and approval (Reports, Technical reports, Procedures, Forms) of process and cleaning validation.
Functions:
- 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.
- Perform investigations and 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.
- Approve NC investigations and CAPA records.
- Approve change controls.
Education
- 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.
Vacante publicada el 16 días atrás
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