Specialist QA 35619

Inteldot; Juncos (PR); On-site; USD 75,000 - 110,000; Full time

Job summary

Inteldot is seeking an Administrative Shift QA professional to support the Quality Assurance program across manufacturing and process validation, ensuring regulatory compliance and quality standards are upheld.

The role emphasizes document review, investigations, and CAPA control within a highly regulated biopharma setting, requiring extensive experience and strong technical writing skills.

Qualifications

• Experience in a biopharmaceutical industry setting.
• Quality organization supporting deviations, validation reports, qualifications, investigations.
• Minimum 5 years in a highly regulated environment.

Responsibilities

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Assist or lead incident triage on QA incidents.

Skills

Biopharma experience

Quality assurance

Technical writing

Education

Doctorate or Masters + 2 years related exp

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:

• Experienced working in biopharmaveutical industry


• Quality organization supporting deviations, validation reports, qualifications, investigations


• At least 5 years of experienced in a highly regulated environment .


• Technical Writing


• 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.