Randstad Document Specialist in Lexington, Massachusetts

Document Specialist

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job details:

  • location:Lexington, MA

  • salary:$32.52 - $38.26 per hour

  • date posted:Monday, October 9, 2017

  • job type:Contract

  • reference:22851

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Process Documentation Writer

7 Months

Lexington, MA

Job Responsibilities

  • Responsible for GMP documentation process in support of manufacturing operations

  • Initiate and revise SOPs, Batch Records and Form Preps.

  • Ensure documents are reviewed periodically to meet or exceed compliance expectations Identify and lead required documentation revisions

  • Address Next Revision Suggestion Form (NRSF) items

  • Provide expertise and leverage best pr actices to technicians and support groups when reviewing draft SOPs and Batch Records/Form Preps

  • Partner with support groups and consult with supervisors and technicians to coordinate documents for major projects or change management

  • Responsible for partnering with support groups for the timely initiation and completion of change controls, CAPAs and subsequent action items

  • Act as the primary liaison with the training group to ensure appropriate training materials are created with new or modified GMP documentation

  • Monitoring and trending effectiveness of documentation modifications

  • Support coordination of documents related to major projects or changes to process or systems

Education & Qualifications

  • Bachelors Degree (or an equivalent combination of education and relevant experience)

  • 0 - 2 years relevant experience in a life sciences-related field.

  • Previous technical writing experience preferred

  • Strong written and verbal communication skills

  • Demonstrate high-level of professional and business judgment when communicating with cross-functional teams and others at all levels of the organization

  • Must be proficient with Microsoft Office applications, including Word, Excel and Power Point.

  • Experience with more advanced document management applications a plus (including but not limited to EDMS and TrackWise)

  • Support continuous improvement efforts to ensure documentation is efficient and compliant

  • Work on projects of routine problems of limited complexity and scope and following established policies and procedures.

  • Identify and analyze opportunities for process improvement.

  • Make certain that documents contain accurate details and instructions corresponding with the activity

  • Ensure that the information contained in documents correspond with the information of related documentation and that they adhere to all GMP requirements