Principal Document Control Specialist

Menlo Park, CA 94025

Posted: 12/03/2018 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 14283

Principal Document Control Specialist

 

PURPOSE OF JOB: 

Responsible for performing all document control related activities to support new product development and commercial activities. Responsible for ensuring training plans and training records are maintained within the Electronic Quality Management System.

 

MAJOR DUTIES AND RESPONSIBILITIES:  

Process Change Orders (COs) using 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 accurate approval assignment per company procedures.

Ensure CO attributes are filled out accurately per company procedures.

Ensure action items required for CO release are accurately followed and completed.

Generate training plans and ensure training records are entered correctly.

Ensure compliance with controlled document format and content.

Publish weekly change orders status reports and work with cross functional management on prioritization of Change Orders.

Provide global search reports in EQMS as requested.

Update Document Control and Training systems’ related procedures as needed.

Support internal and external audits as well as CAPA activities.

Periodically monitor accuracy & maintenance of the training database.

Perform distribution of controlled documents and retrieval of obsolete/superseded documents as needed.

Maintain Laboratory Notebooks.

Perform records archival as assigned.

Periodically inspect/audit-controlled binders and training records to ensure accurate distribution and current training (i.e. correct documents and current revisions) as needed.

Ensure maintenance of all types of quality system records.

Perform other Document Control and Quality System related duties as assigned.

 

EDUCATION / EXPERIENCE REQUIREMENTS:

AA Degree

8 years of experience in the Life Science industry

 

OTHER QUALIFICATIONS: 

Proficiency with WORD, Excel, Power Point and Adobe is required.

Skilled in in technical writing and SolidWorks

Must be organized and have strong attention to detail.

Excellent communication and time management skills required.

Work well with cross functional teams

Work independently with minimum supervision

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 utilization of quality system software such as Oracle Agile Product Life Cycle/ Product Quality Management is preferred.

 

Physical Activities:

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.

 

Physical Requirements:

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.

Visual, Acuity, and Working Conditions:

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.

Jesse Ashworth

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