Abbott

Senior Auditor Clinical Affairs

Abbott • $99K — $198K *
Lake Forest, IL 60045In-Person
Healthcare
5 - 7 years of experience
Reposted Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's Degree in life sciences (biological or related fields)
  • 6-8 years of experience in Quality Assurance or clinical research
  • 3-4 years specifically in QA/GCP auditing
  • Familiarity with both paper-based and electronic data capture systems
  • Proficient in investigative techniques for data analysis
  • Knowledge of CAPA processes
  • Detail-oriented with solid problem-solving skills

Responsibilities

  • Conduct audits independently and guide multiple auditors in a team setting
  • Prepare and maintain a comprehensive audit schedule for GCP activities
  • Monitor and assess internal and external audit results, implementing corrective actions as needed
  • Serve as Subject Matter Expert (SME) during regulatory inspections and audits
  • Prepare reports for Senior Management detailing audit findings and corrective measures
  • Manage files and documentation related to all auditing activities
  • Facilitate the identification and correction of GCP compliance deficiencies

Benefits

  • Opportunity to mentor and train other QA personnel
  • Involves travel to various clinical study sites (up to 50% of the time)
  • Engagement in a range of auditing activities including external and internal site audits
  • Exposure to significant regulatory audits and inspections
  • Collaboration with diverse teams across the division to improve processes
Full Job Description
JOB DESCRIPTION:

The Opportunity

The position of Senior Auditor provides auditing and Quality Assurance activities in order to assure that the systems, processes and performance of internal and external clinical study sites comply with applicable laws, regulations, Standard Operating Procedures, protocols and guidelines and meet Sponsor requirements. Independently conduct or take lead role with multiple auditors, plan and conduct external clinical study audits, internal specimen collection audits, clinical data verifications and master file audits. As SME, mentor/coach/train other internal QA auditing staff, manage contract auditors as well as support internal investigator training sessions. Train and manage other personnel/process to perform data audits to meet submission timelines to Regulatory agencies.

Main Responsibilities

  • Maintains current knowledge of applicable FDA regulations, ICH GCP,FDA regulations and other applicable regulatory standards to maintain effectiveness as an Clinical Affairs Auditor.
  • Conducts audits independently and act as lead when multiple auditors present.
  • Prepares and maintains a Division audit schedule for GCP activities, reviews and agrees to site audit schedules, plans, observations and ratings.
  • Monitor and analyze both internal and external audit outcomes and react/direct/manage as appropriate.
  • Participates in site-led audits of the site's quality system, called upon as an SME during CRQS audits/regulatory inspections as well as perform activities such as scribe and/or document reviewer.
  • Preparation of reports to Senior Management documenting audit activities, metrics, findings and resolutions and raise significant issues of noncompliance.
  • Manage post-audit activities and follow-up on any necessary corrective and preventive actions and resolve any conflicts.
  • Manage and maintain files and documentation associated with all audit activities.
  • The identification/correction of GCP compliance deficiencies along with a successful facilitation of an external inspection/audit could avoid suspension of new product approvals through significant regulatory actions.
  • If not prevented, this action can result in loss of business opportunities and can negatively impact the profitability of the company.
  • Must have a thorough knowledge of Good Clinical Practice (GCP),ICH and FDA regulations and guidelines as must be able to interpret, explain and apply.
  • Must have a proven understanding of Clinical processes and systems and experience with medical device clinical trials and substantial experience with GCP audits.
  • Must have excellent organizational, interpersonal and communication skills both orally and in writing
  • Experienced PC user proficient with Microsoft Word, Excel and PowerPoint.
  • Proficiency in auditing databases, trial master files, investigator sites, statistical/clinical study reports, process/systems, for cause audits.
  • Must be able to evaluate complex systems and determine the level of compliance to regulations and standards.
  • Liaison to all appropriate Division departments/teams to ensure expeditious compilation of projects and corrective action for audit observations..
  • Assist in development of training materials, manages SOPs and process improvement activities.
  • Willingness to travel


Required Qualifications
  • Education: Bachelor's Degree in biology, chemistry, microbiology, or related life sciences.
  • 6-8 years in Quality Assurance or clinical research.
  • 3-4 years in QA/GCP auditing
  • Experience with paper-based data management systems as well as EDC data management systems.
  • Ability to investigate and analyze information and draw conclusions.
  • Require knowledge and training in CAPA.
  • Detail oriented, accurate and able to independently determine and develop approach to solutions.


Preferred Qualifications
  • Certification (ASQ CQA or Lead Auditor)


The base pay for this position is
$99,300.00 - $198,700.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Quality Assurance

DIVISION:
CRLB Core Lab

LOCATION:
United States > Lake Forest : CP01

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Yes, 50 % of the Time

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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