Job Listing: Auditor IV

Our client, a global pharmaceutical company, is looking for an Auditor IV to join their team in R&D.

The responsibilities of the Auditor IV position will be to:
· Influence policies and procedures for compliance evaluation of regulated activities in area of responsibility within R&D.

· Identify areas for and participate in implementation of process improvements and or international harmonization related to compliance across R&D.

· Lead and conduct audits. Issue audit reports and perform follow-up actions, as assigned. Conduct investigations of compliance issues noted during audits and inspections or otherwise observed or reported.

· Review/audit compliance documents, SOPs and validation protocols as assigned. Report findings to Research or Development management as necessary.

· In the absence of the manager or when assigned; organize and host inspections and audits by regulatory agencies, BI compliance groups, and consultants in area of responsibility. Investigate and resolve straightforward to moderately complex observations noted during audits / inspections. Lead and organize inspection readiness activities.

· Maintain acceptable proficiency in technical and non-technical (e.g., interpersonal skills) skills.
· Model and coach colleagues in effective and constructive communication behaviors and interactions with technical departments both orally and in writing.

· Train new personnel as required and develop and implement training programs in the regulatory requirements as requested. Available to act as a resource for colleagues with less experience. Assume the role of manager (when requested).


To be qualified for the Auditor IV position you must have the following qualifications:

- B.S., B.A. or M.S. degree in scientific discipline.
- Minimum of 7 years of GLP audit experience within in the Pharmaceutical industry (preferably in Toxicology)
- Excellent verbal and written communication skills
- Good interpersonal, problem detection, diplomacy and organizational skills
- Detailed working knowledge of US FDA GLP requirements; available to act as a resource for colleagues
- Independent decision making capability and ability to think conceptually and understand overall impact of decisions
- Very good to excellent conflict resolution and negotiation skills
- Proficient in use of MS Office (Word, Excel and Access)
- Willingness to travel approximately 20% of the time, primarily domestic travel

Required Skills for Auditor IV Job:

About Aerotek Scientific:

Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.