Randstad Document Specialist in Lexington, Massachusetts
salary:$32.52 - $38.26 per hour
date posted:Monday, October 9, 2017
Process Documentation Writer
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