Specialist QA

ECHO Consulting Group•Juncos, PR

About The Position

ECHO Consulting Group is seeking a Specialist QA to perform one or more duties supporting its Quality Assurance program under minimal supervision. The role supports pharmaceutical, biotechnology, medical device, and food industry work involving quality assurance, manufacturing, validation, and compliance. It is based in Juncos, Puerto Rico, and is listed as an administrative shift. ECHO describes its workplace as emphasizing trust, respect, teamwork, creative talent, enthusiasm, and diligence, and states that it offers competitive compensation and professional development.

Requirements

  • Education and directly related experience must meet one of these combinations: doctorate degree; master's degree and 3 years; bachelor's degree and 5 years; associate's degree and 10 years; or high school diploma/GED and 12 years.
  • Project management skills.
  • Strong organizational skills, including the ability to follow assignments through to completion.
  • Ability to initiate and lead cross-functional teams.
  • Enhanced skills in leading, influencing, and negotiating.
  • Strong knowledge in area of expertise.
  • Ability to 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.
  • Ability to interact with regulatory agencies.
  • Strong word processing, presentation, database, and spreadsheet application skills.
  • Strong written and oral communication, facilitation, and presentation skills.
  • Ability to work independently and interact effectively with various levels.
  • Advanced data trending and evaluation skills.
  • Ability to evaluate compliance issues.
  • Ability to demonstrate the Values/Leadership Practices.

Nice To Haves

  • Experience with NPI, Change Control, FATs, Validation, and PPQs.

Responsibilities

  • Review and approve product MPs.
  • Approve process validation protocols and reports for manufacturing processes.
  • Request Quality on the incident triage team.
  • Approve Environmental Characterization reports.
  • Release sanitary utility systems.
  • Approve planned incidents.
  • Represent QA on the NPI team.
  • Lead investigations.
  • Lead site audits.
  • Own site quality program procedures.
  • Serve as designee for the QA manager on the 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.

Benefits

  • Competitive compensation package
  • Professional development
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