Job Description:

Description

POSITION SUMMARY:

Responsible for performing aspects of document and records control and operation and maintenance of the training program to establish, perform and ensure compliance with corporate and ISO quality requirements.

DUTIES AND RESPONSIBILITIES:

• Perform all aspects of document control following corporate procedures.


• Participate in the document workflow process to ensure documents are appropriately routed for review and approval

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  Review document submissions to ensure conformance to corporate procedures

  
  


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  Perform document formatting and editing according to templates

  
  


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  Issue, track and audit Controlled Copies of documents

  
  


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  Assist authors in identifying training requirements and issue training tasks at document release

  
  


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  Assist employees with troubleshooting and resolving issues related to word processing applications

  
  


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  Train end users on navigating the Electronic Document Management System and assist with questions as they arise

  
  

• Operate and maintain the training program




• Facilitate the development and approval of training requirements for new hires, transfers and promotions


• Configure employee training requirements in tracking system and manage training tasks


• Assess updates to changes in training requirements and manage training tasks


• Generate and distribute monthly training metrics


• Train end users on training program and assist employees with questions as they arise

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  Archive, retain and preserve records

  
  
  
  
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    Ensure records are maintained in accordance with record retention policies

    
    
  
  
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    Issue, receive, log, scan and archive research notebooks

    
    
  
  
  
  

* Specific duties may vary depending upon departmental requirements

EXPERIENCE AND QUALIFICATIONS:

* Bachelor's degree preferred
o 4+ years of relevant experience may be substituted for a degree
* Minimum of2 years of document control experiencein a pharmaceutical, medical device or biotech industry
o Experience in cGMP and/or ISO environment preferred
* Experience with electronic document management system preferred

• One year of training system experience is desired


• Experience with electronic quality management system/training system is desired


• Experience with conducting end user training in a classroom setting is desired
  * A demonstrated level of consistency in performance and aptitude for managing additional responsibility and accountability are required for next level consideration
  
  KNOWLEDGE, SKILLS AND ABILITIES:
  
  * Competent in MS Office Suite and Windows applications
  o Word, Outlook, SharePoint, Excel , PowerPoint, Visio,Acrobat
  * Proficient in document formatting
  * Competent in document control processes and records management under a structured quality management system
  * Ability to work under limited supervision and manage multiple tasks and prioritize assignments within established time constraints
  * Excellent oral, written communication and interpersonal skills.
  o Effectively communicate issues/problems and results that impact timelines for project completion
  o Ability to interact professionally at multiple levels within a client oriented organization
  * A wide degree of creativity and latitude is expected including the ability to multi-task and work productively in a demanding research environment with changing priorities
  
  PHYSICAL DEMANDS:
  
  This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office.
  
  WORK ENVIRONMENT:
  
  This position is performed in a traditional office environment.

Qualifications