Documentation Specialist

Quality Specialist I

The Quality Specialist I serves as a key first line of defense for the quality laboratories, focusing on documentation, sample management, and compliance rather than hands‑on lab work. The role provides guidance on quality processes, reviews batch records, and determines whether discrepancies can be resolved or should be escalated to the investigations team. The position operates within a robust Quality Management System to support the manufacture of phase‑appropriate material in a state‑of‑the‑art cell and gene therapy facility.

• Operate within the Quality Management System to support the manufacture of phase‑appropriate material in the clinical manufacturing facility (CMF).
• Ensure all product samples are correctly labeled and that all aspects of sample allocation and transfer are accurately documented in the appropriate formats and systems.
• Maintain full accountability for product as it is allocated across various sample requirements and storage conditions.
• Evaluate sample management processes to identify gaps, propose enhancements, and support implementation of process improvements.
• Ensure all documentation is completed, reviewed, filed, and archived in accordance with Standard Operating Procedures (SOPs).
• Maintain compliance with applicable regulatory requirements for cellular and gene therapy products.
• Perform daily tasks in accordance with established policies, procedures, and techniques, applying training, common experience, or working knowledge relevant to the work performed.
• Work under close supervision of senior staff and leadership, seeking guidance and feedback to ensure alignment with quality standards.
• Collaborate effectively in a diverse, cross‑functional team environment by using clear and proactive communication to support high productivity and consistent quality outcomes.
• Document all activities performed in alignment with Good Manufacturing Practices (GMP), current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and quality control standards.
• Support clean room and biology‑related quality activities by ensuring accurate records for molecular assays, technical writing, investigations, and corrective and preventive actions (CAPAs).
• Provide guidance to stakeholders on documentation practices and sample management procedures as needed.
• Assist with backlog reduction efforts, including occasional weekend work on a voluntary basis to help meet operational timelines.

• Bachelor’s degree (BS) in Biology or another relevant science field.
• Experience working in a highly regulated environment with strong documentation practices.
• Experience in a GMP environment is highly preferred; experience in other highly regulated environments such as GLP is also considered.
• Working knowledge of GMP, cGMP, GLP, and QC principles.
• Ability to follow established policies, procedures, and techniques accurately and consistently.
• Strong attention to detail and accountability in sample management and documentation.
• Ability to work effectively under close supervision while following guidance from senior staff and leadership.
• Effective communication skills for working within diverse, cross‑functional, and collaborative teams.
• Competence in technical documentation and record‑keeping related to clean room operations, biology, molecular assays, investigations, and CAPAs.

• Experience with cellular and gene therapy products or similar advanced therapeutic manufacturing environments.
• Familiarity with clean room operations and associated documentation requirements.
• Comfort working in a rapidly growing, startup‑like environment undergoing expansion and change.
• Ability to support technical writing activities, including documentation for investigations and corrective and preventive actions.
• Flexibility to occasionally support weekend work on a voluntary basis to help address workload backlogs.

The role is based in a rapidly growing, state‑of‑the‑art facility focused on cell and gene therapy, with newly built clean rooms and modern equipment. The organization is expanding with additional sites under development, creating a…