Temporary Document Control Specialist

  • 111 Oyster Point Blvd, South San Francisco, CA 94080, USA
  • Contract

Company Description

Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a publicly traded, clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics to improve the lives of patients with serious diseases.  Our industry-leading drug discovery platform, which includes comprehensive proprietary libraries of the extracellular proteome and differentiated screening capabilities, has led to a pipeline comprising five development programs in clinical trials across multiple indications in 2019.  We also have several undisclosed research programs that have the potential to yield our next wave of development-stage therapeutic biologics.  And we continue to fuel this process using our proprietary screens to discover new immuno-oncology targets.

Five Prime is committed to innovation and outstanding science to develop effective new drugs for the treatment of severe diseases. We value our culture of openness, collaboration and productivity.  Discover more about FivePrime at www.fiveprime.com.

Job Description

The Document Control Specialist will provide administrative as well as some technical support in the execution of GXP quality archive management, including processing of documents and executed forms, file transfer and archival of GXP records, filing and storage of paper records and maintenance of both electronic and paper records.

This role will report to our Senior Manager, Quality Assurance.  This is a great entry-level opportunity to gain quality assurance experience in a successful biotech company. 

Responsibilities include:

  • Process and archive electronic GXP records in Veeva QualityDocs
  • Maintain paper and electronic SOP and GXP documentation systems
  • Create and maintain document trackers and indexes for GXP activities
  • Prepare documents for offsite storage, as needed
  • Be flexible and prepared to perform other related tasks and duties as assigned

Qualifications

  • 0-2 years in document or records management in a pharmaceutical cGXP environment
  • Proficient with a computer (MS Office), Adobe Pro, and internet skills
  • Experience working with many file types
  • High school diploma is required, AA degree is desirable
  • Highly organized with attention to detail
  • Great written and verbal communication skills
  • Great working attitude and a strong team player

Additional Information

At FivePrime, we believe a diverse workforce drives our success as a company. We are always working to create an environment where different backgrounds and viewpoints are valued and celebrated.

FivePrime is an equal opportunity employer. FivePrime makes employment decisions, including in recruitment and selection, without consideration of race, color, national origin, religion, sex, gender, gender identity or expression, sexual orientation, age, veteran status or disability.

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