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 Quality Control Digitalization Specialist will be responsible for driving the digital transformation of Quality Control (QC) processes within a cell and gene therapy environment. This role ensures compliance with 21 CFR Part 11, governing electronic records and electronic signatures, while optimizing data integrity, security, and efficiency in QC.
The individual will be the software administrator for QC equipment and responsible for audit trails and QC computer system software lifecycle management. The individual will be responsible for the implementation of paperless solutions for Quality Control. This position will also provide support to assist the QC groups during technology transfer when new equipment is identified and onboarded for Quality Control. The QC Digitalization Specialist will partner with the QC Digitalization Lead, QC groups, the QA computer software validation team, Validation/Metrology, and the IT/Software teams. He/she will be responsible for authoring Standard Operating Procedures (SOPs), user requirements, configuration specifications, traceability matrix, IOPQ test scripts, execution of software validations, and data integrity/electronic signature assessments.
The individual will initiate and complete change controls, deviations, corrective and preventative actions, and laboratory investigations in compliance with all applicable quality systems and current cGMPs, when required.
HOW YOU WILL MAKE AN IMPACT
- Operate and maintain laboratory equipment and instruments, ensuring proper adherence to cGMP Compliance 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.
- Ensure GMP compliance in digital QC workflows.
- 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.
WHAT YOU WILL BRING
- Bachelor's or Master's degree in 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.
- Good knowledge in evaluating and recommending user roles for data integrity.
- Ability to author/revise various documents like, system admin sops, SPEC, Protocols, URS, VAL PLAN.
- 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 on 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/manage activities.
- Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and attention to detail.
- Proficient in MS Office applications and information technologies that support documentation and data management systems.
- Strong troubleshooting, problem-solving skills, oral and written skills.
- Ability to multi-task and interact with multiple groups in a team-oriented environment.
WORKING CONDITIONS
- Monday-Friday
- Flexible shift work. Weekends and holidays may be required on occasion in support of 24/7 manufacturing operations.
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.
At RoslinCT, we offer more than just competitive pay. Our comprehensive Total Rewards package is designed to support your health, financial well-being, and professional development throughout your career. Benefits include medical, dental, and vision insurance, educational assistance, a 401(k) program, and a variety of additional resources to help you thrive both personally and professionally.
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.
