QA Specialist II, Document Control

Wave Life Sciences • Lexington, MA

9h • $98,000 - $133,000 • Onsite

About The Position

As a member of Wave’s Quality Assurance (QA) team, the Document Control Specialist plays a crucial role in ensuring the efficient management, organization, and compliance of all GxP documentation. The Document Control Specialist will organize, maintain and archive physical and electronic records in a systematic manner to ensure quick access and retrieval for audits and Inspections. This role is cross-functional and will work with several departments to ensure proper handling of all GxP documentation.

This is an in-person role onsite at our Lexington facility requiring a minimum of 4 days onsite.

Requirements

• Bachelor’s degree with 2 years of related or transferable experience in the pharmaceutical or biotechnology industry, preferably in Quality Assurance/Document Control
• Have knowledge of cGMP regulations/environment
• Experience with Quality Management Systems
• Experience with electronic document management systems; Veeva experience is preferred
• Proficient with all Microsoft applications (Word, Excel, Adobe, Outlook)
• Strong attention to detail and organizational skills
• Working knowledge of Veeva Quality Vault Docs and QMS
• Working knowledge of GxP and FDA requirements including Current Good Manufacturing Practices (cGMP), Good Documentation Practices, data integrity and Quality Systems
• Excellent team player with strong collaboration skills
• Self-motivated to lead and manage projects
• Lifting up to 30 lb. may be required of boxes containing documents

Responsibilities

• Manage the Document Control Program including document creation, issuance, use and retention at the Lexington facility
• Support the creation and revision of Document Management SOPs, work instructions, batch records and other GxP documents in collaboration with Subject Matter Experts (SMEs)
• Oversee lifecycle of electronic and paper documents, including creation, issuance, reconciliation, archival, retrieval, scanning/uploading
• Review documents for completeness, formatting, and Good Documentation Practices including data integrity
• Issue batch records and logbooks to meet set timelines and ensure timely reconciliation
• Support onboarding activities including ensuring signatures are captured on file
• Train employees on the Document Management System
• Serve as subject matter expert in the electronic document management system (Veeva)
• Manage document periodic review schedule, ensure document reviews are completed on time, and escalate issues to manager
• Maintain an organized and access controlled document control room
• Maintain Disaster Recovery Binders/documents
• Archive documents with Iron Mountain and maintain a tracking system for efficient retrieval
• Lead and manage process improvements to increase efficiency
• Support external audits/inspections by fulfilling document requests in a timely manner
• Manage or support the timely closure of relevant Quality System records
• Maintain and report metrics related to Document Control and provide input for the Quality Management Review
• Support other QA department team members’ needs as identified by management
• Other duties as assigned

Benefits

• company-sponsored medical, dental, vision, life, long and short-term disability insurances
• generous paid time off (including a week-long company shutdown in the Summer and the Winter)
• 401K participation with matching contributions
• Employee Stock Purchase Program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level