Documentation Specialist

Position Title: Documentation Specialist

Work Location: Branchburg NJ 08876

Assignment Duration: 3 months (possible extension)

Work Arrangement: Onsite

Position Summary:

Administers all aspects of the change controls in TrackWise, Document Change Control (DCC) and management of controlled documentation in the EDMS (Electronic Documentation Management System) in accordance with policies and procedures. Reviews and evaluates change requests of varying complexity and makes quality decisions, as needed with no supervision. Evaluates objective data and implementation plans associated with various change requests and follows up on activities required for closure. Serves as a primary contact for change initiators and provides guidance on the process as required. Evaluates and resolves quality issues and provides compliant alternatives. Serves as a SME for Quality Documentation and Change Control during regulatory audits. As team lead provides guidance and direction to other team members.

Key Responsibilities:

• Review, evaluate, and process complex high priority and business critical change requests including:
• Objective data and implementation plans
• Provide guidance to change initiators as required
• Evaluate and resolve quality issues related to change control as required
• Complete processing of change request and associated documentation
• Identify potential process deficiencies and develop solutions for improvement
• Serve as a SME for Quality Documentation and Change Control during regulatory audits
• Assist Quality leadership with special assignments/projects including:
• Participating in cross functional teams for site projects
• Representing Documentation and Change Control on global initiatives
• As a team lead provide guidance and direction to other team members

• Bachelor's degree in Business, Management or related discipline, or equivalent work experience is required.
• Minimum of 5 years of experience within a documentation services group and/or Quality function utilizing a validated documentation management system and change management system (preferably TrackWise) would be preferred.
• Quality or change control experience with an understanding of medical device documentation including, but not limited to, policies, procedures, work instructions, specifications, etc.
• Experience with supporting internal and external audits.
• Previous experience providing training to change initiators as the SME.
• Strong organizational skills; ability to accomplish multiple tasks within the agreed upon timeframes through effective prioritization of duties and functions in a fast paced environment.
• Strong written and oral communication skills, including the ability to present ideas and suggestions clearly and effectively