Abbott

Lead Clinical Lab QA Specialist

Abbott • $86K — $173K *
Madison, WI 53711In-Person
Healthcare
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a scientific field relevant to the position.
  • 4+ years of quality assurance experience in regulated environments.
  • 2+ years of experience leading process and project implementations.
  • Understanding of FDA, CLIA, CAP, HIPAA regulations and standards.
  • Proficient in Epic healthcare software or similar ePHI systems.
  • Experienced with Microsoft Office applications.
  • Strong collaboration and communication skills across functions.

Responsibilities

  • Manage multiple complex QA projects with minimal oversight.
  • Develop and implement quality improvement initiatives.
  • Provide expertise and guidance to Lab QA team members.
  • Investigate and resolve quality assurance issues from lab teams.
  • Lead cross-functional projects with internal and external partners.
  • Maintain confidentiality of sensitive information.
  • Work effectively in a team and adapt to changing circumstances.

Benefits

  • Support from a comprehensive Quality Management System.
  • Opportunity for professional growth through project management leadership.
  • Engagement in continuous improvement initiatives.
  • Work in a collaborative and innovative environment.
Full Job Description
JOB DESCRIPTION:

Position Overview
The Lead Clinical Lab QA Specialist is responsible for the development, implementation, administration, and maintenance of the Quality Management System for the Exact Sciences Laboratories. This role is also responsible for ensuring compliance with all clinical laboratory regulatory requirements. The Lead Clinical Lab QA Specialist will monitor the effectiveness of the quality management system, identify, support, and facilitate continuous improvement opportunities and educate the workforce on applicable procedures and regulations.

Essential Duties
Include, but are not limited to, the following:
  • Independently manage multiple, complex projects simultaneously within defined timelines, prioritizing as necessary, with minimal instruction or oversight.
  • Identify, develop, design, and assist with coordinating improvements.
  • Provide subject matter expertise, guidance, and recommendations to Lab QA team members and other Exact Sciences Lab teams/sites while leading through influence, informal leadership, and best practice advocacy.
  • Investigate, document, and resolve complex quality assurance related concerns received from various lab teams, enterprise teams, and 3rd party vendors.
  • Utilize project management experience to initiate and lead cross-functional projects with both internal and external partners.
  • Ability to interface, work effectively, and conduct themselves in the highest professional manner with all levels of the organization, vendors, customers, etc.
  • Ability to work in a team environment and adapt to and embrace change in projects, workload, and circumstances effectively; able to respond to new information quickly.
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
  • Support and comply with the company's Quality Management System policies and procedures.
  • Maintain regular and reliable attendance.
  • Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 80% of a typical working day.
  • Ability and means to travel between work locations.
  • Ability to maintain confidential information.


Minimum Qualifications
  • Bachelor's degree in a scientific major or field related to the essential duties of the position.
  • 4+ years of professional work experience in quality assurance in a regulated environment.
  • 2+ years of direct experience leading process and project implementation, management, or improvement.
  • Demonstrated understanding and professional working knowledge of FDA, CLIA, CAP, HIPAA, or other applicable regulatory entities and standards.
  • Proficient in Epic healthcare software or other electronic patient medical record (ePHI) software/system.
  • Proficient in Microsoft Office programs.
  • Demonstrated aptitude for learning new processes and software.
  • Demonstrated ability to collaborate across functions with both internal and external stakeholders, and to communicate ideas and opinion in a proactive and professional manner.
  • Exceptional written and verbal communication skills, excellent attention to detail and organization skills.
  • Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
  • Authorization to work in the United States without sponsorship.


Preferred Qualifications
  • Advanced degree in a scientific field related to the essential duties of the position.
  • Experience with (or demonstrated understanding of) specific state regulatory requirements for clinical laboratory operations, such as CA, NY, MD, and FL.
  • Experience with audits or inspections by regulatory bodies, such as CAP, FDA, and/or NY State Department of Health.
  • Additional quality assurance or project management certifications such as Six Sigma or PMP.


The base pay for this position is
$86,700.00 - $173,300.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Quality Assurance

DIVISION:
ONCO Cancer Diagnostics

LOCATION:
United States > Madison : 1 Exact Lane

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), Keyboard use (greater or equal to 50% of the workday)

About Abbott

Abbott Careers

Joining Abbott means becoming part of a globally diverse team dedicated to making a lasting impact on human health. As a leader in healthcare innovation, Abbott provides a dynamic workplace where careers flourish through growth, leadership, and diversity training.

Opportunities at Abbott

Explore a world of opportunities with our team. Whether you're seeking job opportunities in engineering, marketing, research, or healthcare, Abbott offers a variety of positions that allow professionals to grow their careers. Our commitment to diversity and innovation is evident in every aspect of our work, fostering an inclusive culture that values each team member's contribution.

Work You'll Do

At Abbott, every role contributes to our mission of helping people live fuller lives through better health. From groundbreaking research in medical devices to advancements in pharmaceuticals, our team is at the forefront of healthcare innovation. By joining Abbott, you are not just accepting a job; you are embarking on a path of professional and personal growth.

Internship Programs

Kickstart your career with an Abbott internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at Abbott work on projects that matter, gaining the experience and knowledge necessary to succeed in their future careers.

Professional Development

Abbott is dedicated to the continuous professional development of its employees. With access to cutting-edge technology, leadership programs, and diversity training, our team members are equipped to lead and innovate within the healthcare industry. We support your career journey with robust training programs, mentorship, and opportunities for networking and professional growth.

Benefits and Culture

Our employees enjoy comprehensive benefits designed to support their life and well-being. From health insurance to retirement plans, we ensure our team has everything they need to thrive. Abbott's culture is built on a foundation of respect and integrity, united by a shared commitment to improving health outcomes.

Join Our Team

Discover the impact you can make with a career at Abbott. We are hiring individuals who are passionate, curious, and driven to lead. Search open positions that match your skills and interests on our Jobs page. Prepare your resume, sharpen your interview skills, and get ready to join a team that's at the cutting edge of healthcare solutions.

Stay Connected

Keep up to date with career tips, industry insights, and company news—all from the people who work here. Subscribe to our Careers Blog and personalize your subscription to receive job alerts and insider tips tailored to your preferences.

Explore Abbott

With a commitment to improving life through innovation, leadership, and diversity, Abbott is a place where you can fulfill your potential. See what exciting and rewarding opportunities await at Abbott by exploring our career opportunities today.

SEARCH ABBOTT JOBS

Join us in our mission to make the world a healthier place through innovation, leadership, and diversity. Your journey to a fulfilling career at Abbott starts here.
Learn more about Abbott
Size
113,000 employees
Market Cap
$189 billion
Industry
Healthcare
Net Income
$4.4 billion
Founded
1944
5 Year Trend
+15.6%
Revenue
$34.6 billion
NASDAQ
ABT
* Ladders Estimates

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