Senior Auditor Clinical Affairs
Job Location:
Lake Forest, CA - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
Working atAbbott
AtAbbott you can do work that matters grow and learn care for yourself and your family be your true self and live a full life. Youll also have access to:
Career development with an international company where you can grow the career you dream of.
Employees can qualify for freemedical coveragein ourHealth Investment Plan (HIP) PPOmedical plan in the next calendar year.
An excellent retirement savings plan with a high employer contribution.
Tuition reimbursement theFreedom 2 Savestudent debt program andFreeUeducation benefit - an affordable and convenient path to getting a bachelors degree.
A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity working mothers female executives and scientists.
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.
- Maintains current knowledge of applicable FDA regulations ICH GCPFDA 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 sites 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: Bachelors Degree in biology chemistry microbiology or related life sciences.
- 68 years in Quality Assurance or clinical research.
- 34 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)
An equal opportunity employer Abbott welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
The base pay for this position is
$99300.00 $198700.00In specific locations the pay range may vary from the range posted.
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: EEO is the Law link - Espanol: Experience:
Senior IC
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
