Quality Assurance Specialist, MasterControl Documentation and Training Administrator

Location
Boston, MA, United States
Posted
Feb 20, 2021
Ref
839C635AC7
Required Education
Bachelors Degree
Position Type
Full time

The Quality Assurance Specialist is a primary contact/SME for documentation and training for Orchard, responsible for execution of day-to-day operations of the document control and training programs, within the electronic Quality Management System in accordance with GMP standards. The Specialist sets priorities and completes the routing, review, and release of documents by projected timelines and exercises judgement for routine activities required for the document control center.

Documentation

  • Operate and maintain the Electronic Document Management and Training System (MasterControl).
  • Manage document and record workflows within MasterControl
  • Ensures documents sent for approval conform to Orchard policy and SOP
  • Ensures proper archival of GxP documentation
  • As required, scan, index and upload documents and records in to MasterControl
  • Assist in training and support of MasterControl end users
  • Assist in the maintenance of electronic and/or hard-copy archives for applicable GxP.
  • Assist in routing, editing, and finalizing controlled documents, ensuring consistency and compliance to formatting and template requirements.
  • Support external distribution of controlled documents
  • Maintain appropriate filing structure to keep document files identifiable, secure, and easily retrievable when needed. Maintain document database for accuracy of documentation details and location.
  • Prepare and coordinate documentation transfer of Quality documents and records to on-site and offsite storage.
  • Responsible for executing the workflow of the document control department and for training others on document related procedures and processes.
  • Participate in external audits to include providing requested documents, notating, and maintaining log of reviewed documents and maintaining audit history files.
  • User administrator, including creating, changing, and disabling user accounts per approved procedures
  • Configure and deploy new document types and approval workflows as needed
  • Manage document and record workflows within MasterControl
  • Ensures periodic review of controlled documents is performed on time.
  • Provide document support to end users within Orchard.
  • Perform other related duties and projects as assigned.


Training

 

  • Collaborate with document authors to define appropriate training method
  • Coordinate training assignments for employees.
  • Maintain current training curricula and ensure appropriate course assignment
  • Assist with tracking of qualifications and training metrics by generating training reports.
  • Prepare training metrics for Management Review.
  • Maintain training records in accordance with SOP and current practices.
  • Provides guidance and expertise around the Electronic Learning Management System functionality
  • Manage Training requirements, events, and tasks in MasterControl for cross functional stakeholders. This may include training assignments for new hires or transitioned employees, new and revised documents, or new programs.


Requirements

Required knowledge

 

 

  • 2+ Years' Experience in Document Control and Training
  • Previous MasterControl experience required, preferably in a system administrator capacity.
  • Working knowledge of FDA 21 CFR Part 11 and EU Annex 11 requirements for validated electronic systems and data integrity requirements is desirable


Skills & Abilities

 

 

  • Proficiency with Microsoft Office Suite.
  • Demonstrated ability to interact and communicate effectively with peers, senior management, regulatory officials, auditors, contractors, and consultants.
  • Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused entrepreneurial environment.
  • Works with a positive tone and collaborative mindset.
  • Good attention to detail
  • Demonstrates initiative, teamwork, commitment and follow-through with all Document and Training initiatives.


Education

 

 

  • Degree in life sciences, business or other related field or related experience