Associate Specialist Documentation

Title: Associate Specialist Documentation

Location: Alameda, CA

Duration: 12 Months

100% Onsite

Years Experience:

• Minimum 3+ years relevant experience

Skills:

• Knowledge of regulations and standards affecting IVDs and Medical Devices
• Related experience with document control and change order systems
• Working knowledge of QSR, ISO standards relating to document and data control

Education:

• Bachelor’s Degree or an equivalent combination of education and work experience.

Duties:

• This position is responsible for reviewing and processing change requests for new documents and revisions to existing documents; responsible for processing, organizing and maintaining the Document Control System in accordance with applicable quality and regulatory guidelines.
• Responsible for implementing and maintaining the effectiveness of the quality system.
• Create, analyze and process Change Items in compliance with QSR, ISO13485 and other applicable standards.
• Assist in expanding the use of Agile software to increase efficiency of Document Control processes.
• Assist in the development of monthly reports regarding key metrics to track Document Control system effectiveness.
• Participate in project teams to further develop efficient and effective use of Document Services.
• Broaden the scope of the Document Services Functions, such as development of Change Control function.
• Provide customers (internal and external) with technical assistance in Document Control procedures.
• Build and maintain successful cross functional relationships with internal departments such as R&D, Manufacturing, Quality Control, Regulatory Affairs and Operations.
• Ability to clearly, concisely and accurately convey communications.
• Ability to form and develop interpersonal, professional relationships.
• Display socially and professionally appropriate behavior.
• Ability to work independently and in groups.
• Demonstrated initiative and problem-solving skills.
• Critical-thinking skills.
• Ability and aptitude to use various types of databases and other computer software.
• Ability to prioritize.
• Strong organizational skills and ability to manage projects.
• Ability and aptitude to provide solutions and contingency plans through the comprehensive review of alternatives.

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High-Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

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, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.