Document Control Specialist

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POST DATE 9/18/2016
END DATE 10/16/2016

Five Prime Therapeutics, Inc. South San Francisco, CA

South San Francisco, CA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Entry Level (0 - 2 years)


div id="contentwrapper" p strong Five Prime Therapeutics, Inc.  /strong (NASDAQ: FPRX) is a biotechnology company focused on discovering and developing transformative protein-based medicines for patients with serious unmet medical needs.  The company has an emerging portfolio of innovative products for inflammation and cancer and currently has 3 protein therapeutics in clinical testing covering 11 indications. /p ul li style="text-align: justify;" FPA008 – a monoclonal antibody targeting CSF1R in multiple disease areas including six solid tumors and pigmented villonodular synovitis (PVNS) /li li style="text-align: justify;" FPA144 – a monoclonal antibody targeting FGFR2b for selected gastric cancers /li li style="text-align: justify;" FP1039 – A FGF ligand trap in Phase 1b for mesothelioma /li /ul p FivePrime also focuses on developing world-class diagnostic and biomarker strategies for the appropriate therapeutic settings.  FivePrime’s discovery platforms can rapidly interrogate the entire extracellular proteome in medically relevant in vitro and in vivo models leading to novel targets and drug leads.  Our technology has been validated by our growing pipeline and through multiple partnerships with pharmaceutical companies including GlaxoSmithKline, UCB, and Bristol-Myers Squib across a range of therapeutic indications.  Five Prime is committed to innovation and outstanding science, values that are reflected in our people and our products.  /p h2 Position: /h2 p FivePrime Therapeutics, Inc. is seeking a motivated and ambitious individual to join the Quality team as a Document Control Specialist.  The individual will be responsible for administering the Document Control System and GXP Training Program to ensure compliance with Quality objectives and regulatory requirements.  This position will report within the Quality organization. /p p Responsibilities will include but are not limited to the following: /p p u Document Control responsibilities /u : /p ul li style="text-align: justify;" Maintain and continuously improve the Document Control system and processes to ensure compliance with current GXPs. /li li style="text-align: justify;" Work with primary originators of documents to ensure that GXP-related SOPs and forms are reviewed, edited, formatted, and approved in a timely manner. /li li style="text-align: justify;" Author Quality, GMP, and GXP related SOPs and forms as assigned, and work with functional departments to ensure accuracy, feasibility and completeness. .    /li li style="text-align: justify;" Issue Document Change Requests (DCRs) and document status reports. /li li style="text-align: justify;" Update and maintain document tracking spreadsheets, document databases (if any), including data entry for tracking documents. /li li style="text-align: justify;" Provide guidance and training to employees on document control systems and procedures. /li li style="text-align: justify;" Manage the document periodic review program. /li li style="text-align: justify;" Obtain, monitor, and report on document control metrics, and oversee document control compliance for the Quality department. /li /ul p u Training Administration responsibilities /u : /p ul li style="text-align: justify;" Serve as a training representative for Quality with other departments, and as a project resource for training projects, as required.  /li li style="text-align: justify;" Administer the GXP training program at FivePrime, including by maintaining master copies of all FivePrime training materials. /li li style="text-align: justify;" Maintain complete and accurate training records for personnel involved in GXP activities and maintain an active list of all such personnel. /li li style="text-align: justify;" Perform audits on training files to ensure that all GXP employees are meeting their training requirements. /li li style="text-align: justify;" Assist managers and others in creating training curricula, materials, documentation, etc. /li li style="text-align: justify;" Deliver training on document control and/or training procedures and practices as required. /li li style="text-align: justify;" Evaluate the effectiveness of training programs, and implement recommended changes or enhancements when necessary. /li li style="text-align: justify;" Obtain, monitor, and report on training metrics, and managing GXP training compliance. /li /ul p u Quality responsibilities: /u /p ul li style="text-align: justify;" Provide additional support to the Quality organization as required including maintaining original Quality documents, loading PDFs into the Quality SharePoint, updating controlled lists, etc.  /li /ul