Abbott
Clinical Quality Associate(onsite)
Abbott, Los Angeles, California, United States, 90079
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. 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. The base pay for this position is
$57,300.00 – $114,700.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY:
Operations Quality
DIVISION:
MD Medical Devices
LOCATION:
United States > Maple Grove : 6820 Wedgwood Road N.
ADDITIONAL LOCATIONS:
United States > Sylmar : 15900 Valley View Court, United States > Texas > Plano : 6600 Pinecrest
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).
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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. 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. The base pay for this position is
$57,300.00 – $114,700.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY:
Operations Quality
DIVISION:
MD Medical Devices
LOCATION:
United States > Maple Grove : 6820 Wedgwood Road N.
ADDITIONAL LOCATIONS:
United States > Sylmar : 15900 Valley View Court, United States > Texas > Plano : 6600 Pinecrest
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).
#J-18808-Ljbffr