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Specialist QA

Specialist QA

BioPharma Consulting JAD GroupJuncos, PR, US
Hace 9 días
Descripción del trabajo

Job Description

Job Description

We are seeking a highly motivated Quality Assurance (QA) Specialist to support quality systems and manufacturing operations in a regulated pharmaceutical or biotechnology environment. This individual will be responsible for reviewing and approving key documentation, ensuring compliance, leading investigations, and supporting facility and system validations under minimal supervision.

Key Responsibilities :

  • Review and approve Master Production Records (MPs) and process validation protocols and reports.
  • Approve planned incidents , environmental characterization reports , and sanitary utility system releases.
  • Participate in incident triage and serve as QA representative on New Product Introduction (NPI) teams.
  • Lead and support deviation investigations , CAPAs , and change control evaluations.
  • Review and approve risk assessments , work orders , and EMS / BMS alarm responses .
  • Oversee lot disposition and authorize batches for shipment.
  • Represent QA in internal audits , cross-functional meetings, and compliance reviews.
  • Own and maintain site-level quality procedures and participate in quality governance forums.
  • Support automation , facilities , and environmental monitoring programs.
  • Act as QA delegate in local change control review boards when required.

Key Competencies :

  • Strong project management and organizational skills
  • Ability to lead and influence cross-functional teams
  • Analytical thinker with advanced skills in data review and compliance assessment
  • Independent, detail-oriented, and able to manage multiple priorities
  • Confident in written and verbal communication, presentations, and facilitation
  • Capable of interacting effectively at all levels within the organization

    • Requirements

    Required Qualifications :

  • Doctorate degree
  • Master’s degree with 3+ years of directly related experience
  • Bachelor’s degree with 5+ years of directly related experience
  • Associate’s degree with 10+ years of directly related experience
  • High school diploma / GED with 12+ years of directly related experience
  • Background in Science or Engineering required

    • Preferred Qualifications :

  • Experience in QA manufacturing support , including batch record review , investigations , and audit readiness
  • Familiarity with systems such as PAS-X / MES , MAXIMO , SAP , LIMS , and DAI processes
  • Availability to work non-standard shifts , including nights and weekends
  • Strong understanding of GMP regulations , validation , and quality systems
  • Effective communication and collaboration skills across multiple departments

    • Benefits

  • 1 year contract with possible extension
  • Non-Standard Shift- Night shift
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    Qa Specialist • Juncos, PR, US