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Inteldot

Specialist QA 35807

Inteldot Juncos, Puerto Rico

IT Services and IT Consulting · 11-50 employees

4 d ago
qa Mid (2-5 yrs) Full-time Puerto Rico
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About the role

The Specialist QA will support the quality assurance program by managing manufacturing processes, process validation, and regulatory compliance activities. Key duties include leading investigations, approving quality documentation, and ensuring site quality program procedures are maintained.

What they look for

Quality Assurance GMP GDP Change Control CAPA Process Validation Regulatory Compliance Incident Investigation Risk Assessment Electronic Quality Systems Manufacturing Environmental Characterization Automation Facility Programs Work Order Review Lot Disposition

Requirements

Candidates must have experience in GMP manufacturing and quality assurance, specifically with change controls, deviations, and CAPAs. A minimum of a bachelor's degree with 4 years of experience or equivalent combination of education and experience is required.

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:

  • GMP manufacturing experience
  • Experience in Quality Assurance: review and approval of change controls, deviations, CAPAs, protocols, reports, and procedures.
  • Experience supporting packaging/inspection operations
  • Strong knowledge of GDP and electronic quality systems
  • Ability to collaborate effectively with Manufacturing, Engineering, and Process Development.
  • Bilingual English/Spanish communication skills are preferred

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.
  • Lead investigations.
  • Lead site 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.
  • Review and approve EMS/BMS alarms.
  • Approve NC investigations and CAPA records.
  • Approve change controls.
  • Provide lot disposition and authorize lots for shipment

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.

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