Kelly Services Document Control Specialist in Fremont, California

Document Control Specialist - Position -

Document Control Specialist In compliance with FDA ISO regulations, the Document Control Specialist will perform work of moderate scope, exercising judgment with only general supervision. General scope of this position is to maintain product related documentation and the flow of information in the form of controlled documents and engineering change orders, over the life cycle of any given product manufactured at SVMI Fremont site. This position requires frequent use and general knowledge of industry practices, techniques, and standards.

Specifically, Essential Job Functions Maintain document change control process via engineering change control system log, track and process DCOs, maintain material and BOM data Review, process, and release documents with accuracy and format conformance using variety of software packages Maintain electronic files of master active or archived documents native source application files as well as the .pdf viewable files Maintain controlled access to master files and archived documents on SWMI system and /or shared servers Train new hires in document control procedures Maintain and control master files and archived documents and access to them Maintain and updates employee training records Check revised documents and completed change orders to assure the highest level of accuracy and conformance with the approved format and standards Conduct periodic department audits to assure that the appropriate procedures are followed and that the highest levels of compliance are continually achieved Manage the review and approval of changes Develop solutions to a variety of problems Perform other, routine responsibilities: Other duties as assigned. These job requirements are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel.

Requirements Bachelor s Degree in related field or equivalent experience 3 to 5 years in a manufacturing environment preferably in medical device environment in QC or QA Practiced knowledge of cGMP requirements; proven project management skills, computer skills including knowledge of MS Word, Excel, draw programs, and database systems. Proven technical writing and graphic design skills or equivalent combination of education and experience required to perform at this level. Ability to work in a fast-paced environment while managing multiple priorities Operate as a team and/or independently while demonstrating flexibility to changing requirements. There may be continuous sitting for prolonged periods more than 2 consecutive hours in an 8 hour day Employee may be required to lift objects up to 25lbs or more. Employees will be required to work in an air conditioned office space and possibly perform some tasks in our non-temperature controlled warehouse space.

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AboutKelly Services ®

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