Document Control Specialist

Company Description

Sirtex Medical is a global leader in healthcare, with offices in the U.S., Australia, Germany, and Singapore, dedicated to improving patient outcomes.

Our mission is to be at the forefront of minimally invasive cancer and embolization therapies. By partnering with physicians, we aim to provide innovative products that enhance patient outcomes and simplify treatments. Achieving this ambitious goal requires passionate and talented individuals who are committed to making a difference. Our flagship product, SIR-Spheres Y-90 resin microspheres, is a targeted radiation therapy for liver cancer.

To date, we have delivered over >150K doses across 50+ countries, significantly impacting patients' lives worldwide. Our success is fueled by our dedication to serving the medical community, maintaining professionalism, fostering a collaborative work culture, nurturing an entrepreneurial spirit, and continuously pursuing innovation and improvement.

At Sirtex, we are committed to creating a great workplace. We offer a range of benefits, programs, and services to support our employees, ensuring they have opportunities to contribute to our success and advance their careers. Join our inclusive community, where you can collaborate with talented colleagues, bring your ideas to life, and advance your career, all while delivering innovative healthcare solutions to patients.

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.

• 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 Withdraw obsolete and superseded documents from circulation and use and ensure appropriate disposal of documents requiring destruction, with due regard for security and confidentiality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

• 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
• Experience with Veeva a plus
• 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

The target base salary range for this position will range from $70,000 to $88,000 annually. Individual compensation for this job requisition will be based on non‑discriminatory factors, including your geographic location, skills, experience, education and other factors as they relate to the position requirements. Actual compensation may vary depending on the confirmed job‑related skills and experience.

In addition to the expected base compensation, this role is eligible to participate in Sirtex's incentive programs (target bonus of 5% for this position) and benefit plans, which include paid sick and vacation time, health insurance and a generous 401k matching program.

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