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 113,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:Document Control Specialist -Irvine, CAOur 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.WHAT YOU’LL DO Our Irvine, CA office currently has an opportunity for a Document Control Specialist.
You will execute and maintain complaints, efficient Quality Assurance Document Management systems and procedures.
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.Responsibilities:Independently performs routine Document Control activities, including, but not limited to: Process DCO/ECO packages and review for accuracy and completeness.
•Issue and manage QA controlled Log for Parts, Documents, Equipment, lab notebooks and other components.
•Independently facilitate the Document Request process including formatting, coordinating the review and approval process, tracking, and routing controlled documents
•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 employees, file employee 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.
•Prepare document control metrics and reports
•Provide support for audits and regulatory agency inspections
•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
•Initiate and revise applicable Document Control SOPs and Work Instructions, as required.
•Support Calibration System
•Provide backup to QA Specialist
•Other duties as assignedEDUCATION AND EXPERIENCE YOU’LL BRING Required AA degree with 3 years of experience, High School with 5 years of experience or 2-5 years of medical device experience with education and experience in a GMP environment administering Document Control SystemsWorking knowledge of 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
•Ability to analyze and reconcile moderately complex issues
•Must have demonstrated initiative, accountability and manage multiple priorities in a fast-paced environment
•Demonstrate leadership skills through example
•Excellent verbal and written communication and interpersonal skills
•Proficient with computers and word processing software (i.e.
Microsoft Office products)
•Knowledge of Egnyte and Agile.
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: A fast-paced work environment where your safety is our priorityProduction areas that are clean, well-lit, and temperature-controlled Training and career development, with onboarding programs for new employees and tuition assistanceFinancial security through competitive compensation, incentives and retirement plansHealth care and well-being programs including medical, dental, vision, wellness and occupational health programsPaid time off401(k) retirement savings with a generous company matchThe stability of a company with a record of strong financial performance and history of being actively involved in local communitiesLearn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com 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.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter AbbottNews and AbbottGlobalJOB FAMILY:Operations Quality DIVISION:SH Structural Heart LOCATION:United States > Irvine : 2375 Morse Ave ADDITIONAL LOCATIONS:WORK SHIFT:Standard TRAVEL:No MEDICAL SURVEILLANCE:Not Applicable SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link
– English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link
– Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf