Sr. Quality Systems Specialist

3 weeks ago

Hopkinton, United States RoslinCT Full time

WHO WE ARE

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.


THE ROSLINCT WAY

Here at RoslinCT, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people’s development, growth, and the ability to impact patients.


ACCELERATING YOUR FUTURE

The Sr. Quality Systems Specialist is a position responsible for supporting the development, implementation, and on-going management of the Quality Management System, as well as supporting software and computer system implementation and integration. The ideal candidate is experienced in Computer System Validation and Software QA including GAMP 5 Software Development Lifecycle. All levels encouraged to apply.

How You Will Make an Impact:

· Provide expertise on the implementation and maintenance of a Quality Management System (QMS), including but not limited to Deviation, CAPA, Change Control, Document Control, Training, Audits and Inspections.

· Identify and drive improvements and standardization of the Quality Management System

· Perform review/approval of Computer System Validation deliverables

· Support CAPA and Change Control implementation

· Monitor implementation of systems ensuring compliance to SOPs and identifying areas for improvement

· Support review and approval of controlled documents

· Support regulatory inspections and client audits

· Support reporting of KPIs as part of Quality Management Review

· Other duties as assigned.


What You Will Bring:

· Effective problem-solving capabilities.

· Strong oral and written communication skills.

· A highly organized work style that ensures timely execution of tasks.

· A mindset that ensures accurate results.

· Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).


Qualifications:

· 5-8+ years relevant Quality Assurance experience in a pharma/biotech company working within a Quality System, regulated GMP environment and/or computer-related system evaluation / validation. Cell therapy experience a plus.

· Prior experience with implementing and/or executing quality systems, serving as Quality reviewer/approver, and/or continuous improvement initiatives focused on quality systems

· Ability to partner cross functionally and integrate feedback with quality systems

· Ability to work independently to meet objectives and timelines

· Has an awareness of GAMP-5, cGMP and ICH regulations/ guidelines

· Bachelor’s degree in related discipline.

*This is an on-site position with the opportunity for some remote work.


OUR COMMITMENT

All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.

RoslinCT is proud to be an equal-opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.

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