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Sr. QA Specialist

2 months ago

Hopkinton, United States The Lykan Bioscience Hold Full time
WHO WE ARE

We at RoslinCT, are 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 QA Sr. Specialist - Plant Operations is responsible for providing QA support and expertise to manufacturing plant operations. This includes developing QA specific procedures related to product disposition, line clearance and review and approval of GMP documentation including but not limited to Batch Records, Validation Protocols/Reports, and Calibration/Work Order Records and new equipment enrollment. The ideal candidate has worked in a startup environment and/or is familiar with GxP operations. Specialists will also assist, as required, with product receipt, shipment and disposition, line clearance and quality system review / approval in the QA role.

HOW YOU WILL MAKE AN IMPACT
  • Perform QA plant operations activities, including, but not limited to, review and approval of Batch Records, Validation Protocols/Reports, Calibration/Work Order Records and new material and equipment enrollment
  • Monitor implementation of QA specific procedures for compliance and identify opportunities for improvement
  • Work cross functionally and provide QA support for development, review and approval of procedures/workflows for manufacturing, Facilities/Validation and QC.
  • Provide QA review and approval of plant related SOPs and GMP documentation
  • Support product disposition and shipping
  • Support internal audits and GMP readiness
  • Support Health Authority Inspections and Client Audits
  • Mentor personnel within QA and cross functionally on GMP compliance, promote quality culture
Minimum Qualifications
  • 4-8 years of relevant Quality Assurance experience in a pharma/biotech company with internal manufacturing. Cell therapy experience preferred.
  • Prior experience in Quality Assurance Operations focused on support of equipment life cycle and internal manufacturing operations.
  • Prior experience working in contract services and interfacing with clients preferred
  • Ability to partner cross functionally and provide quality support within agreed timelines to support plant activities
  • Ability to work independently to meet objectives and timelines
  • Ability to resolve issues and make decisions of moderate complexity independently and escalate complex decisions as needed.
  • Well versed in cGMP and ICH regulations/ guidelines
  • Strong verbal and written communication skills

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.