Specialist QA 35807
Summary
QA Specialist supporting a life-sciences/pharma manufacturing client in Juncos, Puerto Rico: reviewing and approving change controls, deviations, CAPAs, validation protocols, and lot disposition, plus leading investigations and site audits. Core focus is GMP/GDP compliance, electronic quality systems, and QA in regulated manufacturing.
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:
- GMP manufacturing experience
- Experience in Quality Assurance: review and approval of change controls, deviations, CAPAs, protocols, reports, and procedures.
- Experience supporting packaging/inspection operations
- Strong knowledge of GDP and electronic quality systems
- Ability to collaborate effectively with Manufacturing, Engineering, and Process Development.
- Bilingual English/Spanish communication skills are preferred
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.
- Lead investigations.
- Lead site 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.
- Review and approve EMS/BMS alarms.
- Approve NC investigations and CAPA records.
- Approve change controls.
- Provide lot disposition and authorize lots for shipment
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.