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Inteldot

Specialist QA 35670

Inteldot Juncos, Puerto Rico

IT Services and IT Consulting · 11-50 employees

Yesterday
qa Mid (2-5 yrs) Full-time Puerto Rico
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About the role

The Specialist will support the Quality Assurance program by managing manufacturing processes, process validation, and regulatory compliance activities. Key duties include leading investigations, approving change controls, reviewing risk assessments, and providing lot disposition for shipment.

What they look for

Quality Assurance Change Control Process Validation Regulatory Compliance Project Management Data Trending Risk Assessment CAPA Incident Investigation Manufacturing Processes Technical Writing Presentation Skills Negotiation Cross-functional Leadership Database Management Spreadsheet Application

Requirements

Candidates must possess a Master's degree with 2 years of experience or a Bachelor's degree with 4 years of directly related experience. Strong organizational, communication, and project management skills are required to effectively interact with cross-functional teams and regulatory agencies.

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:

  • Change Control
  • Documentation Review
  • Validation
  • PPQ
  • Project management skills.
  • Strong organizational skills, including ability to follow assignments through to completion.
  • Initiate and lead cross functional teams.
  • Enhanced skills in leading, influencing and negotiating.
  • Strong knowledge in area of expertise.
  • Collaborate and coordinate with higher level outside resources.
  • Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
  • Demonstrate ability to interact with regulatory agencies.
  • Strong word processing, presentation, database and spreadsheet application skills.
  • Strong communication (both written and oral), facilitation and presentation skills.
  • Strong skill in working independently and to effectively interact with various levels.
  • Advanced data trending and evaluation.
  • Ability to evaluate compliance issues

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

  • Masters + 2 years of directly related experience OR Bachelors + 4 years of directly related experience

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