Document Control Specialist

Gaithersburg, MD
Jul 31, 2021
Required Education
Bachelors Degree
Position Type
Full time

Arcellx is a venture-backed, early-stage biotech company focused on the development of novel cell-based cancer therapies.  The company is in Gaithersburg, Maryland and has assembled a team of biotechnology professionals with expertise in biologics discovery, characterization, and development.  Lead products will incorporate proprietary technologies that enhance tumor-specific killing by genetically engineered human immune cells.

Primary Objective

Document Control Specialist position is responsible for performing document control functions such as, implementing and maintaining the Document Control System and the archival process, incompliance with Arcellx's the Quality Management System (QMS) and Regulatory Agency (FDA) requirements. The candidate shall have good knowledge and understanding of the relevant GMP regulations and shall have the required working experience in a GxP document control environment.  The candidate shall be a result-oriented self-starter with good communication skills and a commitment to teamwork and reliability.


The main responsibilities will include but are not limited to:

The main responsibilities will include but are not limited to:

  • Manage the Document Control process according to Acellx's internal procedure.
  • Format documents and issue document number according to internal procedures.
  • Prepare quality documents, records and reports for archival purposes and maintain them for the required time period.
  • Perform Document Control Training.
  • Maintain the Archives according to regulatory requirements and Arcellx requirement.
  • Ensure SOPs and other documents are sent out to the Arcellx personnel for training and the training is completed on a timely manner.
  • Maintain individual training folders/records for Arcellx personnel.
  • Where necessary, manage the external archival site/activities.

Preferred Qualifications:

Minimum 3-5 years of hands-on experience in performing Document Control and archival functions.

Excellent with Microsoft office programs such as, word, excel, power point etc.

Excellent communication skills.


  • Commitment to ethical scientific investigations and rigorous experimental methods.
  • Ability and desire to multitask and function in a fast-paced entrepreneurial environment.
  • Demonstrated ability to think critically and analyze and interpret data independently.
  • Sense of urgency in performance of duties.
  • Interpersonal skills that promote a collaborative and productive.
  • Effective and efficient written and oral communication skills.


Without exception, applicants must submit both a cover letter and resume to be considered for these positions and must have experience in one of the fields listed above.