Principal Quality Assurance Auditor- GCP Auditing experience required (Telecommute) Job in Indianapolis, Indiana US
Purpose of Job:
Working within the Quality Assurance team with minimum supervision to ensure that the quality of the research conducted by the organization is maintained. The Principal Quality Assurance Auditor is responsible for all types of audit including project-specific, system / process, and vendor audits. To assist in the training of a team of Quality Assurance Auditors, as appropriate. To act as the Quality Assurance manager for assigned projects, as required. GCP Subject Matter Expert
Major Responsibilities
Auditing
To 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.
To effectively document audit findings in an audit report and obtain responses in a timely fashion.
To report and present to clinical staff and investigators the findings of audits and provide advice on resolving problems identified.
To prepare investigational sites and OptumInsight facilities for inspection by regulatory authorities.
To facilitate and lead customer audits of the company and or projects.
To lead for-cause investigations and conduct for-cause audits
Training
To train, coach and mentor other Quality Assurance personnel as required.
To train and advise all OptumInsight personnel on current GCP, SOP and quality assurance requirements where necessary.
To review audit reports for other Quality Assurance personnel.
To answer queries and provide advice to OptumInsight personnel and third parties on difficult issues regarding current GCP, SOP and quality assurance requirements where necessary.
Project Management
To act as Quality Assurance project manager for assigned projects. To 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.
To develop and maintain a high level of expertise in the projects assigned and marketplace developments through attendance at internal and external professional meetings.
To participate in internal meetings as required.
To liaise with other departments as necessary.
Standard Operating Procedures
To conduct reviews of OptumInsight SOPs.
To develop new, and review existing, Quality Assurance SOPs. Provide training for QA staff as required.
Customer Relations
Lead all aspect of technical communications with internal and external customers for all aspects of audit.
To participate in internal and external meetings as required.
Lead all aspects of quality and audit interactions with other departments as necessary.
Business Development
Provide 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.
Advisory
To act as a GCP / quality subject matter expert and advisory resource in support of OptumInsight operational needs.
B.Sc. Degree or equivalent
Minimum of six years auditing experience in medical/pharmaceutical field plus three years of relevant work experience.
Knowledge of GCP, GMP and/or GLP regulations
Knowledge of ICH guidelines and the clinical research process
Ability to lead and mentor junior level staff
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
OptumInsight is part of the family of companies that make UnitedHealth Group one of the leaders across most major segments of the US health care system.
OptumInsight is one of the largest and fastest growing health information companies. We specialize in improving the performance of the health system by providing analytics, technology and consulting services that enable better decisions and results. We integrate workflow solutions that deliver data in real-time, and create actionable insights - processing health information that relates directly to and affects one in four patients in the U.S, one in every three Medicaid dollars and one in every five emergency room visits. And we do it all with every action focused on our shared values of Integrity, Compassion, Relationships, Innovation Performance.
What can YOU do with the right information? At OptumInsight, the possibilities and the impact are limitless. No matter what your role is at OptumInsight, you'll be empowered to ask more questions, develop better solutions and help make the health care system greater than ever. It's always fresh. It's always exciting. And it's never been more important.
Diversity creates a healthier atmosphere: equal opportunity employer M/F/D/V
UnitedHealth Group is a drug-free workplace. Candidates are required to pass a drug test before beginning employment. In addition, employees in certain positions are subject to random drug testing.