Specialist QA 35563

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.