Specialist QA 35615
Inteldot · Juncos, Puerto Rico
IT Services and IT Consulting · 11-50 employees
About the role
The Specialist QA will support the quality assurance program by performing manufacturing process validation, regulatory compliance, and quality system activities. They will also review and approve technical documents, manage incident investigations, and represent QA on new product introduction teams.
What they look for
Requirements
Candidates must have experience in quality assurance, validations, and commissioning of manufacturing equipment. A minimum of a bachelor's degree with four years of related experience is required, though higher education levels may reduce the required years of experience.
Full 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:
- 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.
