Document Control Specialist

Company: Abbott Laboratories
Location: Santa Clara
Posted on: February 25, 2021

Job Description:

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries Structural Heart (SH)--Structural heart disease encompasses a range of conditions, from acquired valvular disease to congenital defects of the valves or other heart structures. And we're at the forefront of transforming structural heart therapies, leading the development of more advanced solutions for patient care.-- The Cephea Mitral Valve System is intended to replace the native mitral valve using a percutaneous, transseptal procedure. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of STRUCTURAL HEART disease. We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that, by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care. The Document Control Specialist executes and maintains compliant, efficient Document Control Management system. Generating, submitting, approvals and processing Document Change Order (DCO)/ Engineering Change Order (ECO). Manages and maintain Training Management system and Calibration System along with Document Control Management System. Responsible for maintaining and continuously improving the Document Control Quality Systems in order to support the business and release of medical device and ensure compliance with regulations and established requirements. Key Accountabilities/Core Job Responsibilities : Independently performs routine Document Control activities, including, but not limited to: Process Document Change Order (DCO)/Engineering Change Order (ECO) packages and review for accuracy and completeness. Updating Standard Operating Procedures (SOP),Work Instructions (WI) and other documents. Issue document numbers and manage Quality Assurance controlled Log for Parts, Lot numbers, Documents, Equipment, lab notebooks and other components. Independently facilitate the Document Change Order (DCO/ECO) including formatting, coordinating the review and approval process, tracking and routing controlled documents, and release document in Egnyte/Agile in timely manner. Perform administrative tasks to maintain the document management system Egnyte and Agile. Provide user assistance and training on document control and record management systems, processes, and procedures Perform Document Control training for new and existing employees, file employee training records (both hardcopy and electronic) Send email notification for training required on new released documents and follow up to ensure training is performed in timely manner. Manage employee Training Log to ensure employees are trained on all applicable documents. Follow up for any outstanding required training and update the log appropriate upon receipt of the training records. Perform duties in support of established records management procedures for paper and electronic records and management of the on-site document vault records storage and retrieval Manage and maintain the archival of master documents and records (both hardcopy and electronic) such that required documentation is retrievable and files are accurate, complete and well organized. Manage/participate in projects/assignments that support continuous improvement efforts and department and goals as assigned by Quality Management. Represent Document Control in project and functional meetings Provide general support for the overall Quality System Provide support for audits and regulatory agency inspections Initiate and revise applicable Document Control SOPs, Work Instructions and other documents as required. Support reviewing of Lot History Record and other documents as required. Support Incoming Quality Control (IQC) - duties include scanning and filing IQC documents, updating Log etc. Provide backup to QA Specialist Other duties as assigned Education and Experience: AA degree with 1+ years of experience OR High School with 5 years of experience 2-5 years of medical device experience with education and experience in a GMP environment administering Document Control Systems Preferred Skills/Abilities : Working knowledge of Document Control process/Quality Systems Working knowledge of electronic documentation systems, data retrieval, and electronic file formats as well as GMP-related requirements and guidelines Detail oriented and ability to work effectively in a team environment Knowledge of mechanical drawings/part drawings Ability to analyze and reconcile moderately complex issues Must have demonstrated initiative, accountability and manage multiple priorities in a fast-paced environment Excellent attention to detail and accuracy working in a fast pace environment. Demonstrate leadership skills through example Demonstrate good organization skills. Excellent verbal and written communication and interpersonal skills Proficient with computers and Microsoft Suite e.g formatting, redline, tracking changes, accepting and rejecting changes etc. Knowledge of Quality Management Software. WHAT WE OFFER---- At Abbott, you can have a good job that can grow into a great career. We offer:-- Training and career development, with onboarding programs for new employees and tuition assistance Financial security through competitive compensation, incentives and retirement plans Health care and well-being programs including medical, dental, vision, wellness and occupational health programs-- Paid time off 401(k) retirement savings with a generous company match-- The stability of a company with a record of strong financial performance and history of being actively involved in local communities-- Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.-- Get tailored job recommendations based on your interests.

• JOB ID: 30966677
  • LOCATION United States - California - Santa Clara
  • DIVISION SH Structural Heart
    • TRAVEL Yes, 10 % of the Time
      • MEDICAL SURVEILLANCE Not Applicable
        • SIGNIFICANT WORK ACTIVITIES Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Keyboard use (greater or equal to 50% of the workday) Our business encompasses many different functions and capabilities, which allows you to explore careers in various fields.-- GROWTH PLANNING Growth Planning and Performance Excellence is an annual process through which you'll be able to have open career discussions with your manager to help you determine your own career path and future. TRAINING & NETWORKS We provide a wide range of classroom and e-learning courses to help you develop new skills and enhance your career.-- WE'RE RECOGNIZED AROUND THE WORLD DOW JONES SUSTAINABILITY INDEX BEST CORPORATE CITIZENS FORTUNE CHANGE ---------------------THE WORLD FORTUNE'S MOST ADMIRED COMPANIES JOIN OUR TALENT COMMUNITY We will notify you about relevant positions, and keep you in mind whenever we have interesting opportunities.-- Abbott welcomes and encourages diversity in our workforce including Minorities, Women, Individuals with Disabilities and Protected Veterans. We provide reasonable accommodation to qualified individuals with disabilities. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.

Keywords: Abbott Laboratories, Santa Clara , Document Control Specialist, Other , Santa Clara, California