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:
- Quality Professional with Validations and Commissioning & Qualifications of manufacturing equipment and laboratory bench equipment experience (IOQ, PQ, Functional Test).
- Technical Writing
- Quality Systems (Deviations, Change Control) and Maintenance (PM, Work Orders, Job Plans review and approval) knowledge.
- 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 with validations and commissioning & qualifications of manufacturing equipment and laboratory bench equipment (IOQ, PQ, Functional Test).
- Technical writing skills (preparation and review of reports, procedures, forms, technical reports).
- Knowledge of Quality Systems (Deviations, Change Control) and Maintenance processes (PM, Work Orders, Job Plans review and approval).
- Experience reviewing and approving process and cleaning validation protocols and reports.
- Experience performing investigations, audits, NC investigations, and CAPA records review/approval.
- Ability to represent QA on NPI teams and act as designee for QA manager on local CCRB.
- 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
