Abbott

Senior Specialist Quality Assurance

Abbott • $78K — $156K *
Lake Forest, CA 92630In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Apprenticeship or Bachelor's degree in Life Science, Engineering, or related field required.
  • Minimum 3 years of experience in a Quality or related field, or less with an advanced degree.
  • Direct experience in a Quality or Regulatory Affairs role within GMP settings.
  • Understanding of how quality function supports business operations.
  • Strong problem-solving capabilities and communication skills, with a knack for leading cross-functional teams.

Responsibilities

  • Coordinate complaint handling and track metrics related to quality assurance.
  • Assist in investigations of failures or deviations within the CAPA process.
  • Maintain and analyze product complaint logs, collaborating on inquiries and issues.
  • Draft and revise SOPs and related documents to maintain best practices.
  • Support audit readiness by preparing closure documentation and field action reports.
  • Collect and publish quality metrics, including status reports for compliance requirements.
  • Lead or be part of project teams focusing on continuous process improvement.

Benefits

  • Health and wellness benefits to support employees and their families.
  • Access to comprehensive resources promoting a balanced lifestyle.
Full Job Description
JOB DESCRIPTION:

Senior Specialist Quality Assurance

The Opportunity

At Molecular Diagnostics, we realize the potential of personalized care as the laboratory's most trusted and preferred source for molecular diagnostic solutions. We are a division of Abbott Laboratories, a global, diversified healthcare innovator with a legacy of pioneering work in medical diagnostics.

The Senior Specialist, Quality Assurance role is part of our Molecular Diagnostics Business Unit and is based at either our Des Plaines, IL or Lake Forest, IL location.

This role will conduct quality-related activities in the area of Complaint Handling to deliver consistent, high-quality documents, services, products, and processes that add value to the business. The primary function of the Quality Specialist is to assist in maintaining the quality system.

What You'll Work On
  • Complaints Coordination, Postproduction Risk, CAPA, Surveillance and Maintenance, Field Actions, Metrics, etc.
  • Assist with other support duties as assigned.
  • Participate in the Corrective Action/Preventive Action (CAPA) process, including the investigation of failures or deviations as required.
  • Maintain product complaint logs to identify and report recurring issues to Quality Assurance Management and Product Development. Collaborate with other internal groups to respond to product inquiries and issues.
  • Write and revise SOPs, controlled forms, and related documents to ensure best practices and alignment with current operations.
  • Collaborate with members of the Quality Assurance team working on special projects.
  • Participate on permanent and temporary teams that are process- or project-driven.
  • Become familiar with and serve as a subject matter expert on electronic support systems, including TraqWise, CMSNext, SmartSolve, SAP, and related platforms.
  • Collect, analyze, and publish quality metrics.
  • Assist in the preparation of distribution reports as needed for product information letters and field actions.
  • Support the drafting of field action letters and other field action-related documentation.
  • Reconcile and maintain field action files, ensuring all documentation is complete and appropriately filed in accordance with corporate/division standards to facilitate easy retrieval for audit support.
  • Prepare 806 monthly status reports in support of 21 CFR Part 806 field action requirements.
  • Track recall activities through closure and prepare final closure documentation for each field action file.
  • Support audit readiness activities for internal (site, division, and corporate) and external (FDA, ISO, BSI, TUV, etc.) audits.
  • Handle data requests from other departments pertaining to risk or field action data.
  • Serve as a team member and/or leader on projects focused on continuous process improvement.
  • May own CAPA activities for department CAPAs.
  • Facilitate the post-production risk process in cases involving distributed nonconforming product and may support drafting post-production risk records.


Required Qualifications
  • Apprenticeship or Bachelor's degree in Life Science; Engineering; or closely related discipline is required OR relevant combination of education or experience.
  • At least 3 years work experience in Quality or related field experience; Less experience may be appropriate with advanced degree.
  • Direct experience in a Quality or Regulatory Affairs role in a GMP related industry
  • Demonstrates understanding of how their function supports the business.
  • Demonstrates technical and business competencies that drive results and continuous improvement.
  • Candidate should be flexible, have strong problem-solving skills, excellent written and oral communication skills, and be able to lead cross functional teams.


Preferred Qualifications
  • Experience with post-market quality
  • Experience participating in or supporting both internal and external audits
  • Working knowledge of ISO 13485 (QMS), 21 CFR, IVDR 2017/746, MDR 2017/745, and other international regulations
  • Experience with medical devices containing software
  • Experience working with software management systems, such as ERP systems
  • Proficient in Microsoft Office Word, Excel, and PowerPoint
  • Must have the ability to support business needs across different time zones, as needed
  • Excellent written and oral communication skills
  • Strong organizational and prioritization skills


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

The base pay for this position is
$78,000.00 - $156,000.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Operations Quality

DIVISION:
AMD Molecular

LOCATION:
United States > Des Plaines : DP01

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Not specified

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), 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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