Would you like to work for an emerging leader in the development of novel cell and gene therapies for infectious diseases, monogenic diseases, and cancer?  Does the opportunity to join a company that is expanding their capacity for Research and Development of novel therapies while advancing their clinical pipeline, including the recent Phase one clinical trial for their lead program.

We are seeking to hire an experienced Quality Specialist who is driven to grow and learn as a professional, isn’t afraid to take on new things and can work effectively in a high paced team. In this role you will be the Document Control lead within the Quality department and report directly to the Quality Assurance Director. This group supports the company's regulatory and clinical activities in the emerging field of Cell and Gene therapy. The successful candidate must be skilled and experienced in the practice of quality assurance to support cGxP regulations for Phase I/II Clinical trials and be able to navigate the FDA Quality recommendations for cell and gene therapy products.

Primary Responsibilities:

• Manages the Document Control and Training Programs.

• Receives, reviews and formats QMS documents for review and approval

• Serves as a Document Control Archivist

• Manages the organization of all QA/QC and research records and reports

• Serves as a local system administrator and primary point of contact for the eDMS, documentation/archival process initiatives and other Quality Software

• Assigns and controls the issuance and use of logbooks and laboratory notebooks.

• Trains various teams on newly revised/effective procedures as well as new team members

• Participates in internal/external audits upon request

• Supports New Hire Orientation training

• Performs other activities to support Quality Assurance functions

Skill, Knowledge and Abilities Required:

• BS degree preferred or equivalent level of skill and experience

• Minimum of 2-4 years of technical writing/document experience in the GMP pharmaceutical/biotechnology discipline.

• Experience with MasterControl / QT9 highly desired and preferred

• Experience drafting technical procedures and documents relating to GMP operations with the following skills:

• Highly organized with strong attention to detail and great technical writing ability.

• Ability to manage time, priorities, and multitask effectively.

• Ability to communicate with internal and external stakeholders effectively at various levels

• Ability to coordinate and lead meetings related to job function.

• Ability to work well independently and with minimum supervision and identify gaps within documents/ quality processes.

• High level of computer literacy, including MS Applications and Adobe

Working Conditions and/or Physical Requirements

This is an office role that requires some physical mobility and physical effort. Biohazard precautions are required for working near gene therapy vectors, animal or human blood and tissue, or human pathogens.