Sr. Engineer 35600
Inteldot
Specialist QA 35807
Inteldot· Technical Team
About this role
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.
Frequently Asked Questions
Is the salary disclosed for the Specialist QA 35807 position at Inteldot?
The salary for this Specialist QA 35807 role at Inteldot is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Specialist QA 35807 position at Inteldot located?
This Specialist QA 35807 role at Inteldot is based in Juncos, PR. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Specialist QA 35807 role at Inteldot full-time or part-time?
This is listed as a FULL TIME position. It is posted as a Specialist QA 35807 role in the Technical Team department at Inteldot.
Which team or department does the Specialist QA 35807 at Inteldot belong to?
This Specialist QA 35807 position is part of the Technical Team department at Inteldot. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Specialist QA 35807 position at Inteldot?
Click the "Apply Now" button on this page. You will be redirected to Inteldot's official application portal hosted on breezy where you can submit your application directly.
When was the Specialist QA 35807 job at Inteldot posted?
This Specialist QA 35807 position at Inteldot was posted on Oct 5, 2026. Apply as soon as possible — early applications are often reviewed first.
Specialist QA 35807
Inteldot
You'll be redirected to Inteldot's official application page on breezy.