At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.
Primary Job Function:
To provide 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 verification 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.
Core Job Responsibilities:
Responsible for implementing and maintaining the effectiveness of the quality system.
1. Maintains current knowledge of applicable FDA regulations; ICH GCP; FDA regulations and other applicable regulatory standards to maintain effectiveness as a Clinical Affairs Auditor. 2. Conducts audits independently and act as lead when multiple auditors present. 3. Prepares and maintains a Division audit schedule for GCP activities; reviews and agrees to site audit schedules; plans; observations and ratings. 4. Monitor and analyze both internal and external audit outcomes and react/direct/manage as appropriate. 6. 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. 7. 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. 8. Manage and maintain files and documentation associated with all audit activities.
Position Accountability / Scope:
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 to effectively communicate audit results 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.
Must be able to work well with others on audit meetings; follow-up and closure.
Require knowledge and training in CAPA.
Liaison to all appropriate Division departments/teams to ensure expeditious compilation of projects and corrective action for audit observations.
Ability to investigate and analyze information and draw conclusions.
Detail oriented; accurate and able to independently determine and develop approach to solutions.
Assist in development of training materials; manages SOPs and process improvement activities.
Capable of working in a team as well as independently.
Experience with paper-based data management systems as well as EDC data management systems.
Willingness to travel.
A bachelor's degree is required; preferably in a technical discipline such as biology; chemistry; microbiology; health or life sciences.
Minimum Experience / Training Required:
6-8 years Quality Assurance or experience within a clinical research organization including 3-4 years QA auditing experience, GCP auditing experience and ASQ CQA Certification/Lead Audit Certification/training is preferred. .
United States > Lake Forest : CP01 Floor-3
Yes, 50 % of the Time
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
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
We are a global, broad-based health care company devoted to discovering new medicines, new technologies and new ways to manage health. Our products span the continuum of care, from nutritional products and laboratory diagnostics through medical devices and pharmaceutical therapies. Our comprehensive line of products encircles life itself - addressing important health needs from infancy to the gold...en years.
Abbott has sales, manufacturing, research and development, and distribution facilities around the world, close to where our customers need us to be. We are recognized for our global reach and our ability to serve our customers around the world.