Quality Assurance Documentation Specialist

1 month ago

Lexington, United States T2 Biosystems Full time
Job DescriptionJob DescriptionDescriptionThe Quality Assurance Documentation Specialist will be responsible for supporting the Quality Assurance department in promoting product quality, quality system compliance, and annual quality improvement initiatives aligned with T2 Biosystems’ company goals. Qualified candidates will support the processes for records management, document control, change control, and training through comprehensive paper and electronic systems in compliance with applicable ISO standards and FDA QSR and IVDR regulations. This position reports to the Quality Assurance Manager. 
Responsibilities
  • Coordinates tracking and/or directly reviews and approves document change orders and releases effective documents to the electronic quality system.
  • Manages the accurate filing of current and prior revisions to controlled documents.
  • Assists with onboarding of new team members by creating new employee profiles, working with hiring managers to define training requirements and conducting QMS Introduction Training.
  • Effectively tracks and files completed controlled records such training forms, verification and validation reports, Change Orders, Internal and External Audit reports. etc. and supports their archival into offsite storage. 
  • Participates in internal and external audits and supports timely resolution of audit findings.
  • Administrates the T2 eQMS system including system troubleshooting, workflow improvements, user setup, security access, and training assignments - setting up and generating reports, quality metrics, and supporting the upgrade/expansion of system improvements.
  • Trains, advises, and supports users in the proper use of, searching, generation of part master files, part lists (BOM), categorization, supplier information, file generation, documentation templates, and other aspects of the records, document and change control systems as needed.
  • Works with cross functional teams to prioritize, coordinate and track the review and approval cycle of change requests and change order packages. 
  • Supports the assignment, tracking, and timely completion of training assignments for all team members. 
  • Performs ongoing continuous process improvements focused on documentation systems, metrics reporting, and data analysis.
  • Guides requestors to document templates, requirements and assists with formatting, troubleshooting, change tracking, and other quality concerns. 
  • Understands and follows regulatory requirements associated with protection of proprietary documents and preservation of confidential information.
  • Perform related duties commensurate with functional level and responsibilities.

Skills and Expertise
  • BS degree required. Will consider experience as equivalent to degree.
  • 3-5 years of experience in a medical device or IVD manufacturing company in a Document Control function.
  • Proven experience in Quality Systems with an emphasis on ISO 13485, 21CFR Part 820, and IVDR.
  • Previous experience utilizing advanced functions in Microsoft Office, particularly Excel ,Word Powerpoint, Sharepoint, and Adobe Acrobat Pro.
  • Experience in electronic Quality Management Systems (eQMS). Arena Solutions experience is a plus.
  • SolidWorks, SmartSheet and Oracle ERP experience is a plus.
  • A strong work ethic to generate high quality detailed work under tight deadlines.
  • Excellent interpersonal and communications skills (oral and written). Proven ability to work effectively with project teams and all levels of the organization. 
  • Ability to prioritize and complete tasks under shifting priorities and resource changes.
  • Self-motivated; ability to work independently or within a collaborative environment. 
  • Able to lift 25 pounds.

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