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.
- Review and approve deviations, critical utilities and environmental monitoring trend reports.
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
- 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.
- 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.
Skills Required
- Experience in Quality and Compliance, regulatory audits, validation, characterization, automation validation reports
- Experience reviewing and approving deviations, critical utilities and environmental monitoring trend reports
- Experience approving process validation protocols and manufacturing process reports
- Experience performing investigations and audits, including NC investigations and CAPA records
- Experience approving change controls, work orders, product master plans (MPs), and environmental characterization reports
- Education: Masters +2 years OR Bachelors +4 years OR Associates +8 years OR High School/GED +10 years of directly related experience
- Preferred: Bachelor's degree in a science discipline (Engineering, Biology, Chemistry, Physics, Computer)
- Preferred: More than 10 years in biopharmaceutical industry with over 5 years in Quality
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
