Specialist QA 35563

Inteldot; Juncos (PR); On-site; USD 65,000 - 95,000; Full time

Job summary

Inteldot in Puerto Rico seeks an Administrative Shift QA professional to support quality assurance programs within manufacturing, validation, regulatory compliance, and related QA activities.

Role includes reviewing deviations, environmental monitoring, and utility systems; leading investigations, CAPA records, and change controls while representing QA on the NPI team and owning site quality procedures.

Qualifications

• Experience in Quality and Compliance, regulatory audits, validation, characterization, automation validation reports.
• Review and approve deviations, critical utilities and environmental monitoring trend reports.

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

Regulatory compliance

Audits

Validation

Deviations review

Environmental monitoring

CAPA investigations

Education

Masters + 2 years direct experience

Bachelor + 4 years direct experience

Associates + 8 years direct experience

High school/GED + 10 years direct experience

Bachelor in sciences (Engineering/ Biology/Chemistry etc.)

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:

• Experience in Quality and Compliance, regulatory audits, validation, characterization, automation validation reports.
• Review and approve deviations, critical utilities and environmental monitoring trend reports.

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

• Massters + 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.
• Preferred: Bachelors in sciences with concentration in any science discipline such as Engineering, Biology, Chemistry, Physis, Computer, etc. More than 10 years in a biopharmaceutical industry with over 5 years in Quality, as a minimum.