MV01-112224 Quality Assurance Specialist Night Shift

14 hours ago

Juncos PR, United States Validation & Engineering Group, Inc Full time

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

  • Specialist QA [Night Shift (5:00 PM to 5:30 AM 2-2-3)]

Summary

Perform one or more of the following duties and responsibilities in support of the Quality Assurance program under minimal supervision.

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 degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience.

Competencies/Skills:

  • 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.

Preferred:

  • Fluent in English and Spanish, including writing.
  • Strong English technical writing skills.
  • Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues.
  • Problem solving skills.
  • Experience working with dynamic cross-functional teams and abilities in decision making.
  • Strong organizational skills, including ability to follow assignments through to completion.
  • Strong leadership capabilities and experience applying GMP requirements in an operational setting.
  • Ability to independently interact with various levels, drives tasks to completion, and is a self-starter.

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