ACTUAL TITLE: Documentation Specialist
Location: Marlborough, MA 01752
Duration: 12 Months
• Create, revise, and/or archive documents in the document control system.
• Document control and assembly of engineering documents in support of operation
• Prepare/participate in design reviews for product development.
• Ensures all required signatures are included on project documentation
• Support Document Change Request (DCR) processes; word-process final version of new or revised documents for approval
• Resolve documentation issues with collaboration of subject matter experts and technical staff
• Create new and revise existing SOPs, training guides, and checklists as necessary
• Work within Clients Quality Management System
SPECIFIC SKILLS REQUIRED
• In-depth understanding of multi-level Assembly and Sub-Assembly Bills of Material (BOM’s) and configuration management
• Working knowledge of Engineering Change Orders (ECO) and/or Engineering Change Request (ECR)
• Proficient in use of product data management systems
• Documentation, specification and test protocol creation and review
• Familiarity with bio-pharma industry and regulated industry standards, guidelines and best practices
• Highly detailed-oriented with solid organization skills
• Ability to “figure things out,” understand workflow and suggest improvements
• Self-directed and motivated with ability to handle multiple tasks and synthesize disparate information
• Ability to prioritize and adapt quickly to changing needs
• Customer service oriented
• Performance driven with an understanding of how to work collaboratively with cross-functional teams
• Positive and enthusiastic attitude
• Experience with Technical Writing
• Excellent written and verbal communication skills required for documentation process.
EDUCATION AND EXPERIENCE:
• Education: Bachelor’s degree in business, engineering or a related discipline ~ or ~ 5 years of document control experience
• Experience: 3-5 years related experience in clerical, change control process management, administrative related disciplines.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Other: Computer skills required. Knowledge with Microsoft Office (Word, Excel, OneNote, Outlook), Adobe Acrobat.