Documentation Specialist

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

Responsibilities:

• Drives and facilitates the timely change, approval and release of documentation according to project schedules, including the resolution of resource issues relative to the creation (e.g. word processing work).
• Performs all aspects of complex engineering changes, including ECO/ Change Action (CA) processing, parts lists (BOM’s) changes, ERP input, manufacturing processes and general document verification. 
• Monitors configuration and documents changes management process effectiveness including the impact of changes and takes the initiative to recommend configuration and change management process improvements. 
• Assists in the implementation and maintenance of documentation and configuration assurance processes for the control of review, revision, distribution, production, retrieval of records associated with device master records, design history records and other quality records using document management applications. 
• Facilitates the timely release and changes of documentation with documentation authors and approvers (from many levels of the organization) according to project schedules. 
• Ensures process work flows are smooth and timely. 
• Assures all documentation requirements are in compliance with specifications and standards 
• Communicates status of documentation and its configuration to engineers, project managers, managers and senior management as requested. 
• Defines and maintains departmental quality record systems. 
• Participates in the performance and personal development of technical and clerical functions. 
• Prepares and conducts presentations of technical information concerning specific projects/schedules and trainings, etc. 
• Handles and documents CAPA’s, NCR’s and participate during Internal and External audits. 
• Assists the supervisor in the development and training department process, procedures and computerized databases. 
• Uses the DMAIC process to make recommendations of improvements to the documentation process on the site. 
• Identifies the Quality Records required by development and manufacturing according to internal policies and Regulatory requirements. May include the analysis and interpretation of the policies/procedures and trend data. 
• Participates in and leads special projects as assigned. 
• Performs other position related duties as assigned. 

Qualifications Requirements/Knowledge/Education/Skills:

• Bachelor’s degree completed.
• 3 years of experience with various aspects of document control including but not limited to, creating, reviewing, formatting, preparing and routing GMP documents in a documentation control system particularly EDM or Documentum.
• Previous experience within the regulated industry is highly preferred.

Physical Requirements and Working Environment: 

• While performing the duties of this job, the employee is regularly required to use hands to finger, handle, feel, or operate equipments, tools, or controls. The employee frequently is required to stand, walk, talk, or hear; sit; climb or balance, stoop, kneel, crouch or crawl; and smell. The employee may lift and/or move up to 25-35 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and the ability to adjust focus.
• He / she may frequently work inside weather conditions, near moving mechanical parts, exposed to wet and or humid conditions, and an odorous atmosphere, may be exposed to fumes and the risk of electrical shock, and occasionally work on ladders in high places, in small spaces, such as lift/metering stations, manholes, tanks and wet wells. The noise level in the work environment is usually moderately loud.