Posted to MedZilla on 11/13/2019


Takeda Pharmaceuticals

US-MA, Senior Lab Documentation Specialist R0013145-MZ


 
 

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Job Description

OBJECTIVES:

  • Maintains and develops effective quality and documentation systems appropriate for a Discovery setting Coordinates and ensures appropriate documentation for the Vaccine Discovery Clinical Testing Laboratory

ACCOUNTABILITIES:

  • Write and review standard operating procedures (SOPs), laboratory procedures, equipment instructions, knowledge- based documents and business policies.
  • Audit reports and aid in preparation of documents for submission to Quality Assurance and regulatory agencies.
  • Ensure data and reports are in compliance with regulatory standards, applicable SOPs, policies, procedures.
  • Generate document templates for general use. Create laboratory records, equipment records and log books
  • Coordinate clinical sample handling, chain of custody, and tracking records Submit data and reports to Regulatory for inclusion in dossiers.
  • Manage discovery documents and training in CLIX, a learning management system (LMS), to help plan, deliver and assess training.
  • Train technical staff and management in quality and documentation procedures, including good documentation practices, handling and review of electronic laboratory notebooks, data and reports.
  • Assist with internal inspections and ensuing corrective/preventative actions.

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

  • B.S degree in a scientific discipline with 2+ years laboratory experience, preferably in a clinical testing laboratory, Quality, R&D or Discovery
  • Must have experience working in a GXP environment
  • Experience with Electronic Laboratory Notebooks is desirable
  • Familiarity with regulatory processing and submissions.
  • Must have experience writing and reviewing technical documentation, ideally have experience with advanced functions of Microsoft Word.
  • Experience working with and training cross functional groups.
  • Must be creatively open to new ideas and methods and work with a spirit of continuous improvement and innovation.
  • Must have a comprehensive understanding of good documentation practices and strong attention to detail.
  • Ability to identify, report, and seek prompt corrections as they arise.

PHYSICAL DEMANDS:

  • Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

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Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


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