Specialist QA 35619

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.