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:
- Experienced 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.
Skills Required
- Experience working in the biopharmaceutical industry
- Experience supporting deviations, validation reports, qualifications, and investigations in a quality organization
- Minimum 5 years of experience in a highly regulated environment
- Technical writing skills
- Technical document review and approval (reports, procedures, forms) for process and cleaning validation
- Education: Doctorate OR Masters + 2 years OR Bachelors + 4 years OR Associates + 8 years OR High school/GED + 10 years of directly related experience
What We Do
Inteldot offers custom turn-key systems, systems integration, MES eBR configuration and integration solutions, business intelligence and analytics and technical staffing. We have been providing the Pharmaceutical, Manufacturing and Medical Device industries with services for a variety of applications since 2004
