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Document Control Specialist Jobs in New Jersey

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Job Title: Document Control Specialist II
Company: NetSource, Inc.
Location: Somerville, NJ

Description:
Please note that this is a 1 year contract position. EDUCATION: Bachelors of Arts (BA) or Bachelor of Science (BS) degreeKEY SKILL / KNOWLEDGE REQUIREMENTS: SKILL SETS:Interpersonal skills to deal effectively with internal & external customers * all levels.Ability to work in a team environmentAbility to organize and manage project documentationCommunication / presentation skills * verbal and written. Technical writing skills, a plusAbility to compose documents / presentations from minimal notes.Strong organizational and time management skills; able to take complex, ambiguous situations & organize into sensible & well planned functionsDetail-oriented High degree of confidentiality / sensitivityAbility to listen and take direction, seeking clarification where necessaryOperate commonly used office equipmentAbility to work through conflicting information to find solutionsEffective problem analysis and solvingAbility to work independently, with little supervision, to ensure timely completion of tasksWorking knowledge of ISO (International Organization for Standardization) and FDA (Food & Drug Administration) records management requirements preferredCOMPUTER SKILLS:Personal computer software Windows, word processing, presentation, e-mail, flow charts, calendar & spreadsheet softwareKnowledge of Internet requiredKnowledge of Internal Intranet and business applications (such as ECCS [Internal Change Control System] and eDHF [electronic Design History File]) a plus.Takes initiative to update knowledge of new software relevant to the position.JOB EXPERIENCE:3+ years experience as a documentation specialist supporting pharmaceutical or medical device product development activities Experience in quality systems compliance a plus.KEY JOB RESPONSIBILITIES: POLICIES: Know & follow Internal policies & procedures related to work activities performed in area of responsibilityTRAINING: Complete training in area of responsibility within allowed time-period. Training is required for changes in existing policies & procedures, for new assignments & for implementation of new policies & procedures. Complete required periodic re-training in areas such as safety & environmentalSAFETY: Follow all company safety policies & other safety precautions within work area. Promote safety to all associates that enter work areaProvide documentation support to project teams: including:Organize and maintain project team documentation (electronic and/or hard copy) to comply with Corporate Quality System regulations through product release. Formatting documentation and inputting into Corporate Quality Control systems (ECCS, eDHF)Collecting supporting design control documentation; working with assigned team(s) to do so.Submitting documentation for approvals and insuring timely responsesDrafting documents under product engineer oversightMigrate documentation into Internal document management and design history file systemsTransfer control of project team documentation to Corporate Document Services upon product release.Support project teams during internal & external agency audits as requiredAssist Sponsor Teams and Project Leadership Teams during technical design & gate reviewsOther responsibilities may be assigned & not all responsibilities listed may be assignedFor consideration please include Dice # 5454




Job Title: Document Control Specialist
Company: Digital Technology Solutions
Location: Somerville, NJ

Description:
Document Control Specialist with Records Management experience Document Control Specialist Location: Somerville / NJ Duration: 1 year Description: Manages release and control of updates to instructions, drawings and other documents. Controls distribution of new releases and recall-destruction of obsolete documents. Support the records management project objectives. Prepare periodic status reports. Accurately sort, file, mail and copy critical-vital records. Accurately input data in a database spreadsheet and provide reports as requested. . Provide documentation support to project teams: including: Organize and maintain project team documentation (electronic and/or hard copy) to comply with Corporate Quality System regulations through product release. Formatting documentation and inputting into Corporate Quality Control systems. Collecting supporting design control documentation; working with assigned team(s) to do so. Submitting documentation for approvals and insuring timely responses Drafting documents under product engineer oversight Migrate documentation into Client document management and design history file systems Transfer control of project team documentation to Corporate Document Services upon product release. Support project teams during internal & external agency audits as required Asist Sponsor Teams and Project Leadership Teams during technical design & gate reviews Skills Requirements: 3+ years experience as a documentation specialist supporting pharmaceutical or medical device product development activities Experience in quality systems compliance a plus. Working knowledge of ISO (International Organization for Standardization) and FDA (Food & Drug Administration) records management requirements preferred Strong organizational and time management skills; able to take complex, ambiguous situations & organize into sensible & well planned functions Detail-oriented Personal computer software - Windows, word processing, presentation, e-mail, flow charts, calendar & spreadsheet software Please forward your profiles to Register to View -it.com




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