Document Control Specialist

Menlo Park, CA

Posted: 07/22/2019 Employment Type: Contract Industry: Medical Device Job Number: JOS000008794

Performs Document Control activities and maintains Training plans and records as well as provides administrative support for the Company’s Quality System. 

MAJOR DUTIES AND RESPONSIBILITIES: 

  • Process Change Orders (COs) using Electronic Quality Management System (EQMS) in a timely manner with high level of accuracy in compliance with company procedures. 
  • Collaborate with Change Order Initiators to ensure accuracy of the change orders. 
  • Ensure compliance with controlled document format and content. 
  • Ensure accurate approval assignment per company procedures. 
  • Ensure item dispositions are filled out accurately per company procedures. 
  • Maintain Document Control and Quality System related document retention, databases and logs (e.g. training records, laboratory notebooks, off-site records archival log, etc.). 
  • Perform distribution of controlled documents and retrieval of obsolete/superseded documents. 
  • Maintenance of user accounts in Electronic Quality Management System (EQMS). 
  • Work with hiring Managers/Supervisors to ensure accurate & timely submission of employees’ training plans. 
  • Entering training records in EQMS in a timely manner. 
  • Update training roles and associated documents as necessary in EQMS. 
  • Extract and distribute training reports in controlled binders (including updating reports in Controlled Environment Room). 
  • Update training related documents (SOP, WI, FRM, etc.) as necessary. 
  • Assist EQMS users for EQMS issues as assigned. 
  • Participate in audit preparation and other audit related activities. 
  • Scanning, filing and maintenance of all types of quality system records. 
  • Perform other Quality System related duties as assigned. 

EDUCATION REQUIREMENTS: 

High school diploma. Associate or Bachelor’s degree preferred. 

EXPERIENCE REQUIREMENTS: 

Familiarity in Document Control, Training Record Management or similar Quality Systems related role with at least 3 years’ experience in medical device, pharmaceutical, or related industry. 

OTHER QUALIFICATIONS: 

  • Must be proficient with WORD, Excel, Power Point and Adobe. 
  • Must be able to work independently with minimum supervision. 
  • Organized and detail oriented. 
  • Must be organized and have strong attention to detail. 
  • Excellent communication and time management skills required. 
  • Ability to learn quickly and prioritize tasks in a fast paced and dynamic environment. 
  • Knowledge of FDA QSR/cGMP/ ISO 13485 is required. 
  • Proficiency with SolidWorks and Electronic Document Management systems preferred 

PHYSICAL ACTIVITIES AND REQUIREMENTS, VISUAL ACUITY, AND WORKING CONDITIONS: 

  • Walking: Moving about on foot to accomplish tasks, particularly for long distances or moving from one work site to another 
  • Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers 
  • Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. 
  • The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes. 
  • The worker is subject to inside environmental conditions: Protection from weather conditions but not necessarily from temperature changes. 

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