Quality Assurance Specialist

hace 1 mes


Guaynabo, Guaynabo, Puerto Rico Validation & Engineering Group, Inc A tiempo completo

Job Description:

Department: Field - FG Location: Available to work in various locations Job Type: Full-time Job Category: Quality Assurance

About Us:

Validation & Engineering Group, Inc. is a leading services supplier providing solutions for various industries.

Job Summary:

We are seeking a talented individual to work under the highest ethics standards in the following role:

  • Quality Assurance Specialist
  • Shift: Mon/Tue then Fri/Sat/Sun on alternate weeks from 5:00 AM to 5:30 PM or from 5:00 PM to 5:30 AM.

Responsibilities:

  • 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.

Requirements:

  • Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience.
  • Available to work extended hours, possibility of weekends and holidays.

Qualifications:

  • 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.

Company Description:

Validation & Engineering Group, Inc. is a leading services supplier providing solutions for various industries.



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