Senior Auditor Clinical Affairs

Abbott • Lake Forest, CA

21h • Onsite

About The Position

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.

Requirements

• 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.

Nice To Haves

• Certification (ASQ CQA or Lead Auditor)

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

Benefits

• 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 a 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior