Intellectt Inc

QA Validation Engineer

Intellectt Inc Rensselaer, NY
Intellectt Inc

QA Validation Engineer

Intellectt Inc Rensselaer, NY
1 month ago 26 applicants

See who Intellectt Inc has hired for this role

Job Title: QA Validation Specialist

Location: Rensselaer, NY

Experience: 3+ Years

Skills: BMRAMS, BDMS, GMP/GDP, Validation

Industry: Pharma

Job Overview: Client is seeking a QA Validation Specialist to join one of our largest pharmaceutical clients. This role is based onsite 5 days a week in Rensselaer, NY. The individual will be a key member of the Facilities Compliance Team, focusing on documentation and certification of technical adjustments made by onsite vendors.

Key Responsibilities

  • Collaborate cross-functionally between the Facilities Compliance Team and Quality Assurance.
  • Generate detailed documentation for review with QA.
  • Utilize technical understanding of the certification process to justify technical adjustments made by certifiers.
  • Confirm calculations from vendors, analyze raw data, and compare data to transcriptions on reports.
  • Defend proposed adjustments when challenged by QA.
  • Ensure compliance with regulations in a highly regulated environment.
  • Maintain high standards of documentation and technical accuracy.

Required Experience And Skills

  • Experience: 3+ years of industry experience in areas such as QA, QA validation, validation documentation, technical documentation, validation certification, or cleanroom certification.
  • Technical Skills: High proficiency in Microsoft Word and Excel.
  • Technical Understanding: Ability to read and understand technical documents.
  • Communication: Excellent communication skills, particularly in cross-functional settings.
  • Regulatory Experience: Experience in highly regulated environments such as cleanrooms, biotech, or hospitals.
  • Certifications: Experience with or around certifications, including cleanroom certification and HIPPA filter involvement.

Preferred Qualifications & Skills

  • Systems Knowledge: Experience with BMRAM or BDMS systems.
  • Documentation Standards: Understanding or experience with GDP/GMP documentation.
  • Bachelor’s degree in a relevant field such as life sciences, engineering, or a related discipline is preferred.
  • Relevant certifications in QA validation or cleanroom certification are advantageous.

  • Seniority level

    Mid-Senior level

  • Employment type

    Contract

  • Job function

    Engineering and Information Technology

  • Industries

    Pharmaceutical Manufacturing

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