Senior Quality Assurance Specialist

3 weeks ago


Hopkinton, Massachusetts, United States Roslin CT US Holdings,LLC Full time
Job Overview

ABOUT US

At RoslinCT, we are at the forefront of cell and gene therapy contract development and manufacturing. Our dedicated team is committed to advancing innovative therapies through the application of state-of-the-art scientific techniques.

COMPANY CULTURE

RoslinCT fosters an environment of innovation and trust, empowering our employees to contribute meaningfully. We provide a flexible workplace, competitive benefits, and emphasize the importance of work-life balance to ensure the well-being of our team.

POSITION SUMMARY

The Senior QA Specialist for Plant Operations is responsible for delivering expert support to our manufacturing processes. The ideal candidate will possess substantial experience in GxP operations and startup settings. Key responsibilities include the evaluation of GMP documentation, assisting in product disposition, and ensuring adherence to quality system standards.

KEY RESPONSIBILITIES

  • Conduct QA activities related to plant operations
  • Oversee compliance and pinpoint areas for enhancement
  • Work collaboratively across departments to develop and assess procedures and workflows
  • Review and sanction plant-related Standard Operating Procedures (SOPs) and documentation
  • Assist with product disposition, internal audits, and regulatory inspections
  • Guide personnel on GMP compliance and promote a quality-focused culture

QUALIFICATIONS

  • 4-8 years of experience in Quality Assurance within the pharmaceutical or biotechnology sectors
  • Experience in QA Operations supporting the lifecycle of equipment
  • Background in contract services and client engagement
  • Excellent communication skills and a solid understanding of cGMP regulations

OUR COMMITMENT

RoslinCT is dedicated to fostering a diverse and inclusive workplace where every individual is respected. As an equal opportunity employer, we celebrate diversity and welcome candidates from all backgrounds.



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