Documentation Specialist

ACTUAL TITLE: Documentation Specialist
Location: Marlborough, MA 01752
Duration: 12 Months



GENERAL TASKS
 • 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
 
 CANDIDATE ATTRIBUTES
 • 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. 

Thank you,
Sachin P.,
510-574-7988
sachin@apninc.com

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