Sr. QA Auditor- i3- Cary, NC, San Diego, CA, Ann Arbor, MI, or Basking Ridge, NJ

UnitedHealth Group is an innovative leader in the health and well-being industry, serving more than 55 million Americans. Through our family of companies, we contribute outstanding clinical insight with consumer-friendly services and advanced technology to help people achieve optimal health.



i3 is a global pharmaceutical services company that provides integrated strategies and solutions throughout the product lifecycle.  We provide focused therapeutic and scientific expertise in development and real-world evidence during commercialization, all backed by the rich healthcare data and experience of our parent company, UnitedHealth Group. By applying scientific expertise throughout the product lifecycle, i3 helps companies gain better insights that lead to better patient care. As a UnitedHealth Group company, i3  is part of a worldwide health care service organization that uses innovation, integrity and commitment to prepare for the future - and you can prepare for yours with us. It's a rare combination for success that only a career with i3 can provide

 

We currently have a need for a Senior Quality Assurance Auditor to be located in one of our following offices; Cary, NC, San Diego, CA, Ann Arbor, MI, or Basking Ridge, NJ

 

Senior Quality Assurance Auditor is responsible for all types of audit including contract laboratories and other contract research facilities.


 

? Assist in the training of a team of quality assurance associates/assistants.

? Act as the quality assurance manager for assigned Ingenix Pharmaceutical Services projects.

? Conduct internal and external audits of documentation, sites, databases, reports, processes and systems to ensure compliance with SOPs and applicable guidelines/regulations and local laws in relation to the conduct of clinical research.

? Effectively document audit findings in an audit report and obtain responses in a timely fashion.

? Report and present to clinical staff and investigators the findings of audits and provide advice on resolving problems identified.

? Assist in preparing investigational sites for inspection by regulatory authorities.

? Facilitate customer audits of the company and or projects.

? Train other quality assurance personnel as required.

? Assist with training and advise to all Ingenix personnel on current GCP, SOP and quality assurance requirements where necessary.

? Review audit reports for other quality assurance personnel.

? Answer queries and provide advice to Ingenix personnel and third parties on difficult issues regarding current GCP, SOP and quality assurance requirements where necessary.

? Act as quality assurance project manager for assigned projects.

? Include attendance at project team meetings where appropriate, advising team members, management of the quality assurance project budget and assignment of project work to quality assurance personnel as appropriate.

? Develop and maintain a high level of expertise in the projects assigned and marketplace developments through attendance at internal and external professional meetings.

? Participate in internal meetings as required.

? Liaise with other departments as necessary.

? Assist in the organization of the review procedure, distribution, approval and tracking of SOPs. Also to assist with the SOP training for staff as required.

? Develop new (and review existing) quality assurance SOPs.

? Liaise with internal and external customers for all aspects of audit.

? Participate in internal and external meetings as required.

?   Liaise with other departments as necessary.

? Assist in providing input into proposals which include quality assurance activities.

? Assist with business development of external quality assurance services.

? Accompany business development colleagues on customer visits and participate in presentations when required.


Bachelor Science Degree or equivalent.
Minimum of four (4) years auditing experience in medical/pharmaceutical field plus three (3) years of relevant work experience.
Knowledge of GCP, GMP and/or GLP regulations.
Knowledge of ICH guidelines and the clinical research process.
Ability to work in a proactive and reactive environment.
Ability to deal with complex and difficult situations alone.
Demonstrable record of achievement that shows considerable initiative.
Good problem-solving skills.
Computer literate.
Enjoys frequent travel.

Diversity creates a healthier atmosphere: an equal opportunity employer, M/F/D/V.