QC Digitalization Specialist

About Us

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.

Here at RoslinCT, our team contributes 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, and we focus on developing our corporate culture, people’s development, growth, and the ability to impact patients.

Responsibilities

• Drive the digital transformation of Quality Control (QC) processes within a cell and gene therapy environment, ensuring compliance with 21 CFR Part 11.
• Serve as the software administrator for QC equipment, managing audit trails and QC computer system software lifecycle.
• Implement paperless solutions for Quality Control and support technology transfer for new QC equipment.
• Partner with the QC Digitalization Lead, QC groups, QA computer software validation team, Validation/Metrology, and IT/Software teams.
• Author Standard Operating Procedures (SOPs), user requirements, configuration specifications, traceability matrix, IOPQ test scripts, and execute software validations.
• Conduct data integrity and electronic signature assessments.
• Initiate and complete change controls, deviations, corrective and preventative actions, and laboratory investigations in compliance with cGMPs.
• Operate and maintain laboratory equipment and instruments, ensuring cGMP and Part 11 compliance.
• Assist in the implementation of electronic QC systems to ensure compliance with 21 CFR Part 11.
• Execute and maintain audit trails, electronic signatures, and data security protocols.
• Collaborate with IT, Quality Assurance, and Regulatory teams to validate digital systems.
• Oversee the transition from paper-based QC records to electronic documentation.
• Train QC personnel on digital systems and Part 11 requirements.
• Conduct periodic internal audits to assess compliance and system integrity.
• Stay updated on FDA regulations and industry best practices for digital QC.

Requirements

• Bachelor's or Master's degree in a scientific discipline, Quality Management, or related field.
• 1-5 years of experience in QC digitalization within biopharma or cell therapy.
• Strong knowledge of 21 CFR Part 11 and GMP regulations.
• Experience evaluating and recommending user roles for data integrity.
• Ability to author/revise documents such as system admin SOPs, specifications, protocols, user requirements, and validation plans.
• Experience planning and coordinating system upgrades or expansions for lab systems and instruments.
• Good understanding of data management processes related to lab systems and instruments.
• Knowledge of deviation processes, CAPA, change controls, and reporting status.
• Experience with LIMS, ELN, and other digital QC platforms.
• Excellent project management and communication skills.
• Ability to independently prioritize and manage activities.
• Proficient in MS Office applications and information technologies that support documentation and data management systems.
• Strong troubleshooting, problem-solving, oral, and written skills.
• Ability to multi-task and interact with multiple groups in a team-oriented environment.

Schedule

• Monday-Friday with flexible shift work.
• Weekends and holidays may be required on occasion in support of 24/7 manufacturing operations.

Pay

Final compensation will be based on a variety of factors, including education, experience, technical expertise, specialized skill sets, market demand, internal equity, and business needs.

Benefits

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