QC Digitalization Specialist

RoslinCT US•Hopkinton, MA

5d•$65,000 - $98,000•Onsite

About The Position

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.

Requirements

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.

Responsibilities

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.