Specialist QA 35807

Inteldot; Puerto Rico; On-site; USD 65,000 - 95,000; Full time

Job summary

Inteldot, a life sciences partner with operations across Puerto Rico, the United States, Europe and Japan, is seeking an Administrative Shift QA professional in Puerto Rico. Under minimal supervision, you will support the Quality Assurance program across manufacturing, process validation, regulatory compliance and QA activities.

Key responsibilities include reviewing change controls, deviations and CAPAs; leading investigations; site audits; and ensuring readiness for inspections, with

Qualifications

• GMP manufacturing experience required.
• Experience reviewing and approving change controls, deviations, CAPAs, protocols, reports, and procedures.
• Experience supporting packaging/inspection operations.
• Strong knowledge of GDP and electronic quality systems.
• Able to collaborate effectively with Manufacturing, Engineering and Process Development.
• Bilingual English/Spanish communication skills are preferred.

Responsibilities

• 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.

Skills

GMP manufacturing experience

Quality Assurance: change controls, DE

Packaging/inspection operations

GDP knowledge and electronic quality

Cross-functional collaboration

Bilingual English/Spanish preferred

Education

Doctorate OR Masters + 2 years related exp OR Bachelors + 4 years related exp OR Associates + 8 years related exp OR High school/GED + 10 years related exp

Job description

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.