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CMC Document Specialist - United States  

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Posted on : 06 April 2017

Project Description

Job Type : Contract
Career Level : Experienced (Non-Manager)
Education : Bachelor's Degree
Location : Lexington MA US
Job Description :

PerkinElmer is a global technology leader driving growth and initiative in the Environmental and Human Health Science markets. The company is a leading force in the development, production, marketing, servicing, and support of laboratory instrumentation and ancillary services throughout the world.

Job Title:  CMC Document Specialist
Location: Lexington, MA
Duration: Long term

Primary Duties
  • Under the direction of the line manager, the Contract R&D Pharmaceutical Development Documentation, Training and Compliance Specialist is responsible for supporting all the documentation and training needs.
  • Provide documentation and training coordinator services to the PD department including numbering, version control, formatting, processing, and filing of documents.
  • Update training profiles, maintain training records and submit document records within our electronic training tracking system.
  • Assist with documentation and training projects.
  • Document issuance, version control, manual and electronic files maintenance, and document status notifications.
  • Creating monthly metrics.
  • Follow-up on documents biennial review process.
  • Perform logbook creation, review, scan, and file function.     
  • Document formatting, printing and update document trackers.
  • Create training profiles, update training profiles on paper and electronic system, create training reports, maintain training metrics, etc.
  • Perform administrative functions in our training tracking system: update training profiles, updates documents records, etc.     
  • Assist with training and documentation projects.
Education and Experience Requirements
  • Bachelor’s degree required.
  • Experience in Biopharmaceutical industry is preferable.
  • Documentation experience required (paper-based and as well as electronic system).
  • Training system experience required (paper-based and as well as electronic system).
Key Skills, Abilities, and Competencies:
  • Minimum 1 year experience is required.
  • Microsoft Suite detailed knowledge is must.
  • Familiarity with style and formatting within MS word is must.
  • Microsoft Excel pivot table’s knowledge is required.
  • TrackWise and MasterControl or other similar training system knowledge and experience is must.
  • Must be able to work independently but also be customer service oriented.
Complexity and Problem Solving
  • Emphasis on excellent customer service.
  • Must be able to work independently.
  • Prioritization decisions will be made by line manager.
  • Able to solve problems and escalate issues to line manager.
Other Job Requirements:
  • Working hour’s flexibility to meet deadlines as needed.
  • Ability to work overtime as needed.     

Benefits at PerkinElmer

Competitive base salary and incentive compensation plan / Job training and professional development / Comprehensive benefits package / Paid time off and holidays / Tuition reimbursement plan / 401(k) with match