Quality Assurance Specialist (1-year contract with possibility for conversion)

The Quality Assurance Specialist reports to the Technical Lead of QA and will play a key role in managing electronic quality management system, including but not limited to EDMS (Electronic Documentation Management System) and ETMS (Training Management System) and supporting QA activities, such as audits and authority inspections. The position is full-time on-site in our Burlington, MA office. 
The key responsibilities of the position include, but are not limited to, the following:

• GxP Document Management:
  
  • Assigned and managed QMS (Quality Management System) document numbering and document change control.
  • Managed the Lifecycle (creation, distribution, revision, retire and obsolete) of GxP documents. Also, sorting, archiving, and retrieving electronic and hard copy documents.
  • Maintain and archive electronic signature in compliance with SOP and CFR Part 11 requirements.
  • Manage creation and periodic review of QMS SOPs. Draft and revise QA relevant controlled documents. Also, coordinate and assist in the establishment, review and revision of QMS relevant controlled documents by other departments.
• GxP Training:
  
  • Develops and maintains GxP training curriculum, training material library. Responsible for archiving and retrieval of completed training records.
  • Delivers training to staff utilizing various media and methodologies as appropriate including how to use and access documents.
• Assembling support team and organizing request documents for authority inspection/ third party audit.
• Supporting QA in supplier and vendor qualifications, audits.
• Other QA related job duties as assigned by manager

Qualifications and Experience:

• Bachelor's degree in health science, biology/biotechnology, pharmacy, or related field;
• 2+ years of pharmaceutical industry experience with Quality background in a GxP environment, clinical study development projects and/or commercial programs;
• Understanding of applicable ICH guidelines and FDA regulations;
• Experienced in authority inspection (FDA, EMA, ANVISA) and/or third party audit (ISO, NCDQS) are preferred;
• Ability to communicate effectively in a cross-functional team environment and demonstrate relationship building skills;
• Ability to work both independently with direction and within functional teams, to attain group goals;
• Flexible schedule to maintain timelines, shifting priorities and accommodate occasional early/evening meetings with global teams in our Headquarter in Taiwan and affiliates/subsidiaries.