Document Control Specialist

Sirtex • Woburn, MA

1d • $70,000 - $88,000 • Hybrid

About The Position

The Document Control Specialist manages the QMS, specifically handling documents under regulatory control and administering the electronic QMS (eQMS) to ensure the availability, accuracy, and control of all related documents and records. Candidates for this role must live in the Boston/Woburn, MA area and be willing to be onsite a minimum of 3 days/week to align with our hybrid work structure.

Requirements

• Bachelors degree required
• 4 years of experience as a Document Controller highly preferred
• Experience in developing, using various electronic data management systems
• Experience working in the medical device or pharmaceutical manufacturing industry highly preferred
• Excellent written and verbal communication
• Excellent organizational skills and attention to detail
• Ability to work independently, multitask and coordinate activities across a range of functional areas
• Strong analytical skills
• Excellent team skills

Nice To Haves

• Experience with Veeva a plus

Responsibilities

• Maintain the Document Control System for Compliance and required Quality System documentation in accordance with defined systems and procedures
• Maintain associated hard copy and electronic documents and data files
• Assist in the preparation of new documents, records and control systems
• Identify, store, control and retain internal and external documents and electronic files in accordance with Regulatory and Quality System requirements
• Responsible for final approval and release of document through the Document Change Requests Control System and review, amend and issue associated documents
• Oversee obsoleting of documents. Withdraw obsolete and superseded documents from circulation and use and ensure appropriate disposal of documents requiring destruction, with due regard for security and confidentiality
• Maintain formal filing of (with suitable accessibility and retrieval) of all nominated current and archived hard copy documents and record
• Assist during Internal Quality System audits and other duties related to the operation of the Compliance and Quality functions as may be needed from time-to-time

Benefits

• Diverse and flexible work arrangements to achieve the optimum balance between work and personal responsibilities.
• A culture of respect, diversity, collaboration, and innovation fostering inclusiveness and superior performance.
• Attractive compensation and benefit packages which are practical, robust and equitable.
• A commitment to support ongoing professional growth through career development, on the job experiences and training opportunities.
• Challenging work which supports the development of new and better ways to improve clinical outcomes for oncology treatment around the world.
• An unwavering commitment to company values, employee safety and excellence in everything we do.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees