• Job Description

  Req#: 31104160
  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 114,000 colleagues serve people in more than 160 countries.
  JOB DESCRIPTION:
  Working at Abbott
  At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
  • Career development with an international company where you can grow the career you dream of.
  • Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
  • An excellent retirement savings plan with high employer contribution
  • Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
  • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
  • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
  For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.
  The Opportunity
  Our team currently has an opportunity for a Clinical Quality Associate. This new team member will be responsible for supporting Global Clinical Affairs personnel globally in ensuring compliance with medical device and GCP regulations and standards, as well as company policies and procedures and other applicable requirements. Responsible for compliance with applicable regulations and standards, as well as Corporate and Divisional Policies and procedures.
  This position is onsite at our Maple Grove, MN; Plano, TX; or Sylmar, CA sites.
  What You’ll Work On
  Responsible for supporting Global Clinical Affairs personnel globally in ensuring compliance with medical device and GCP regulations and standards, as well as company policies and procedures and other applicable requirements.
  Responsible for compliance with applicable regulations and standards, as well as Corporate and Divisional Policies and procedures.
  
  Study Support
  • Review study documents; identify compliance concerns to applicable regulations, standards, and internal procedures

  • With oversight and mentorship, act as a resource to clinical study teams regarding compliance solutions to meet requirements of regulations, standards, and Abbott procedures

  • Contribute to WI/procedure development related to execution of clinical research projects

  • Understanding of principles of GCP regulations and standards, including 21 CFR Parts 50, 54, 56, 812 and ISO 14155

  • Internal/External Audits

    • Support preparation for internal and external audits

    • May perform internal assessments and quality checks as assigned

    • Support project teams in preparation for regulatory authority inspection or audit, or corporate or divisional regulatory compliance audit

    • May support other clinical quality tasks as requested and as need arises.

  • CAPA & General

    • May support CAPA related tasks, including review of documentation for accuracy and completeness

    • May support other areas of the clinical quality system as needed: training, document control, etc.
  Job/Technical Knowledge
  • Understanding of Good Clinical Practice (GCP) including U.S. regulations and international standards, as well as other relevant regulations and procedures is an asset

  • Cooperation/Teamwork: team player with autonomy capable of working independently under minimal supervision

  • Planning and organizational skills: organizes self in an efficient manner

  • Problem solving: gathers information before making decisions; weighs alternatives against objectives and arrives at reasonable decisions

  • Adaptability: remains open-minded; performs a wide variety of tasks and changes focus quickly as demands change

  • Initiative / Innovation: explores alternative successful ways of working and tools; able to challenge conventional practices; creates novel solutions to problems
  Education and Experience
  Required
  • Bachelors' Degree (preferably in Life Sciences) or equivalent education and experience.
  • Strong communication skills
  • Strong computer skills including Microsoft Office applications
  Preferred
  • Prefer GCP experience; prior audit exposure would be an asset.
  • At least 2 years of medical devices, clinical research experience, or related industry.
  Apply Now
  Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
  Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. 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.
  The base pay for this position is
  $60,000.00 – $120,000.00
  In specific locations, the pay range may vary from the range posted.
  JOB FAMILY:
  Operations Quality
  DIVISION:
  MD Medical Devices
  LOCATION:
  United States > Texas > Plano : 6600 Pinecrest
  ADDITIONAL LOCATIONS:
  United States > Sylmar : 15900 Valley View Court
  WORK SHIFT:
  Standard
  TRAVEL:
  Yes, 5 % of the Time
  MEDICAL SURVEILLANCE:
  No
  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)
  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

• About the company

  Abbott Laboratories is an American multinational medical devices and health care company with headquarters in Abbott Park, Illinois, United States.

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