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QA Validation, Senior Associate

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Proclinical

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Location:
United States , Boston

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

90.00 - 97.00 USD / Hour
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Job Description:

Proclinical is seeking a Senior Associate, Quality Assurance Validation to provide leadership and oversight of validation activities across facilities, utilities, equipment, and computerized systems. This role ensures compliance with regulatory requirements, industry standards, and internal policies while maintaining inspection readiness. You will collaborate cross-functionally to support GxP validation activities and drive continuous improvement in quality processes.

Job Responsibility:

  • Oversee the validation lifecycle, ensuring documentation accuracy, completeness, and compliance with regulations and internal procedures
  • Collaborate with teams across Validation Engineering, IT, Manufacturing, and other departments to develop and maintain risk-based validation strategies
  • Ensure validation activities align with regulatory expectations, including FDA, ICH, NIST, GAMP 5, and PIC-S guidelines
  • Provide quality input, review, and approval for change controls, deviations, CAPAs, and risk assessments to mitigate risks to product quality and data integrity
  • Promote inspection readiness through proactive issue identification and collaboration across GxP functions
  • Embed data integrity principles into all validation activities, systems, and documentation
  • Represent Quality Assurance Validation on project teams, offering strategic guidance and quality oversight
  • Utilize data-driven and risk-based methodologies to support effective validation outcomes
  • Demonstrate leadership behaviors that align with core values and foster a culture of quality and compliance

Requirements:

  • A degree in Science, Logistics, or a related field is preferred
  • Strong knowledge of GxP regulations and ability to apply them to validation and operational activities
  • Hands-on experience in areas such as Quality Assurance, Quality Control, Manufacturing, Technical Support, Facilities Engineering, or Computerized Systems/Automation
  • Proficiency in managing change controls, deviations, and CAPA processes
  • Excellent cross-functional collaboration skills to drive compliant and practical outcomes
  • Highly organized and capable of managing multiple priorities in a team-oriented environment
  • Effective verbal communication skills to convey quality expectations clearly
  • Exceptional technical writing skills for validation and quality documentation
  • Adaptability and flexibility in a fast-paced, evolving environment
  • Continuous improvement mindset with a focus on innovation and process enhancement

Additional Information:

Job Posted:
March 04, 2026

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