Specialist QA 35615

Inteldot; Juncos (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

Inteldot in Puerto Rico is seeking an Administrative Shift professional to support the Quality Assurance program by performing responsibilities across manufacturing, process validation, regulatory compliance, and quality assurance activities.

The role requires a quality professional with experience in validations (IOQ, PQ, Functional Test), technical writing, and strong understanding of Deviations and Change Control, as well as maintenance-related reviews.

Qualifications

• Quality professional with validations and commissioning qualifications for manufacturing and lab equipment.
• Technical writing proficiency.
• Experience with Deviations, Change Control, and maintenance (PM, Work Orders).
• Review and approve process documentation (reports, procedures, forms).

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.
• 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.

Skills

Quality Assurance

Technical Writing

Deviations

Change Control

Regulatory compliance

Education

Doctorate or Masters + 2 years related experience

Bachelor + 4 years related experience

Associates + 8 years related experience

High school/GED + 10 years related experience

Tools

IOQ

PQ

Functional Test

Maintenance (PM, Work Orders)

Job description

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.