QA Specialist I – Plant Ops

About the role

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 QA Specialist I– Plant Operations is responsible for providing QA support and expertise to manufacturing plant operations. The ideal candidate also has experience with batch review and Lot Disposition, as well as Cell and Gene Therapy experience.

How You Will Make An Impact

• Create, issue, and maintain batch records and labels.
• Review and approval of executed batch documentation.
• Review and approval of GMP documentation such as EM exceptions, Calibration/Work Order Records, equipment activation, various process-associated forms.
• Monitor implementation of QA specific procedures for compliance and identify opportunities for improvement.
• Support product disposition, packout and shipping.
• Provide QA review and approval of plant operations related procedures.
• Promote quality culture among personnel.

Minimum Qualifications

• Minimum 2–5 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 internal manufacturing operations.
• 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 low to moderate complexity independently and escalate complex decisions as needed.
• Versed in cGMP and ICH regulations/guidelines.
• Strong verbal and written communication skills.

Benefits

• Medical, dental, and vision insurance.
• Educational assistance.
• 401(k) program.
• Additional resources to support health, financial well-being, and professional development.