Document Control Specialist at Sirtex

Woburn, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

31 Mar, 26

Salary

88000.0

Posted On

31 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Document Control, Quality Management System, Electronic Data Management, Medical Device Industry, Pharmaceutical Manufacturing, Veeva, Written Communication, Verbal Communication, Organizational Skills, Attention to Detail, Analytical Skills, Team Skills

Industry

Medical Equipment Manufacturing

Description

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 Job Description 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 Qualifications 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. Additional Information Do you want to be part of something bigger? A team whose impact stretches across the globe making a real difference to the quality of people’s lives. Sirtex recognizes that well-being, financial health, and work-life balance are crucial for our employees to achieve personal success. Sirtex offers qualified candidates: 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. Diversity drives innovation; inclusion fosters belonging, growth and success. Sirtex believes that it takes multiple perspectives and voices to create a culture and workplace which fosters engagement, teamwork, and employee satisfaction to perform our best and deliver on commitments. We are dedicated to fostering an environment where all employees feel valued, included, and can share their ideas so that we can exceed even our own expectations. Sirtex is An Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age or any other characteristic protected under applicable law. Sirtex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Compensation: USD70122 - USD87653 - yearly

Responsibilities

The Document Control Specialist manages the Quality Management System (QMS) and ensures the accuracy and control of all related documents and records. Responsibilities include maintaining the Document Control System, overseeing document approvals, and assisting during internal audits.