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Inteldot

Specialist QA 35619

Inteldot Juncos, Puerto Rico

IT Services and IT Consulting · 11-50 employees

Yesterday
qa Senior (5-10 yrs) Full-time Puerto Rico
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About the role

The Specialist QA will support the quality assurance program by performing manufacturing process validation, regulatory compliance, and quality oversight. Responsibilities include reviewing technical documents, managing incident investigations, and representing QA on NPI and incident triage teams.

What they look for

Quality Assurance Process Validation Regulatory Compliance Technical Writing Deviation Management Investigation CAPA Change Control Risk Assessment Environmental Characterization Audit Manufacturing Processes Biopharmaceutical Industry Quality Management Systems

Requirements

Candidates must have at least 5 years of experience in a highly regulated biopharmaceutical environment with expertise in deviations, validation, and technical writing. Educational requirements range from a Doctorate to a High school diploma depending on the years of directly related 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:

  • 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.

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