Senior Quality Assurance Specialist
3 weeks ago
ABOUT US
RoslinCT is a premier organization specializing in cell and gene therapy contract development and manufacturing. Our workforce consists of skilled and passionate professionals who collaborate to develop transformative therapies through advanced scientific methods.
COMPANY CULTURE
At RoslinCT, we foster an environment of innovation and trust, empowering our employees to make impactful contributions. We provide a flexible workplace, competitive benefits, and emphasize work-life balance to enhance our team's success.
POSITION SUMMARY
The Senior QA Specialist for Plant Operations will deliver expertise and support to our manufacturing facilities. The ideal candidate will possess substantial experience in GxP operations and startup settings. Key responsibilities include the review of GMP documentation, assisting with product disposition, and ensuring adherence to quality systems.
KEY RESPONSIBILITIES
- Conduct QA activities related to plant operations
- Oversee compliance and pinpoint areas for enhancement
- Engage in cross-functional collaboration for the development and assessment of procedures and workflows
- Review and authorize plant-related SOPs and documentation
- Assist with product disposition, internal audits, and regulatory inspections
- Guide personnel on GMP compliance and foster a quality-centric culture
QUALIFICATIONS
- 4-8 years of experience in Quality Assurance within the pharmaceutical or biotechnology sectors
- Proficient in QA Operations supporting equipment lifecycle management
- Experience in contract services and client engagement
- Excellent communication skills and knowledge of cGMP regulations
OUR COMMITMENT
RoslinCT is dedicated to cultivating a diverse and inclusive workplace where every individual is respected. As an equal opportunity employer, we celebrate diversity and welcome individuals from various backgrounds.
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