Specialist QA 35845

Inteldot; Juncos (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

Inteldot is seeking an Administrative Shift QA professional in Puerto Rico to support the Quality Assurance program across manufacturing, process validation, regulatory compliance, and QA activities. You will review documentation, ensure GMP adherence, and participate in continuous improvement.

The role requires hands-on experience in GMP manufacturing, NPI, change control, FATs, validation, PPQs, and bilingual English/Spanish communication.

Qualifications

• GMP manufacturing experience required.
• Experience with New Products Introduction activities, Change Control, FATs, Validation, and PPQs.
• Bilingual English/Spanish communication skills.

Responsibilities

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Support QA on incident triage and CAPA records.
• Review Environmental Characterization andEMS/BMS alarms as needed.
• Represent QA on NPI team and participate in site audits.

Skills

GMP manufacturing

NPI processes

Change control

FATs & Validation

PPQs

English/Spanish bilingual

Education

Doctorate/Master's + 2 yrs OR Bachelor's +4 yrs OR Associate +8 yrs OR HS/GED +10 yrs

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 with New Products Introduction activities, Change Control, FATs, Validation, and PPQs
• Bilingual English/Spanish communication skills

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.
• Participate investigations and 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.

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.