Job Listing: Pharmaceutical QA Auditor

Our client, a pharmaceutical company with a focus on small molecule therapeutic product development, is looking for a Pharmaceutical QA Auditor to join their team for a 6 - 9 month contract. The hours for this position will be Monday through Friday from 8 am to 5 pm.

The responsibilities for the Pharmaceutical QA Auditor position are:
- Contribute to the development and implementation of Quality Assurance systems.
- Responsible for analyzing regulatory related compliance issues, preparing corrective actions and development of quality reports. Assist in assigned investigations (e.g., audits, product complaints, discrepancies, CAPA and production) and propose appropriate corrective and preventative actions for associated issues and events relating to pharmaceutical production operations and associated quality systems. Assist with the timely completion of investigations and implementation/completion of corrective/preventative actions.
- Evaluate potential vendors/contractors to ensure vendors/contractors compliance and understanding of applicable regulations and industry standards. Perform and document external audits of suppliers, vendors and contract manufacturers to identify deficiencies and non-conformances, assess and report the level of compliance to regulatory and quality requirements, and assure that suppliers implement corrective actions.
- Establish effective working relationships with key Quality personnel at CRO's to ensure effective management of activities and services that are conducted at these locations.
- Ensure that GMP systems at CRO's are compliant with regulatory expectations and are being executed in during all phases of our studies.
- Interpret relevant regulations and apply them to manufacturing programs.

To be considered for the Pharmaceutical QA Auditor position you must have the following qualifications:
- BA/BS in Life Sciences or equivalent
- 5-8 years of GMP QA experience in biotechnology/pharmaceutical industry
- Demonstrate working knowledge of regulations and guidances
- Experience working with pharmaceutical development organizations and providing oversight to CRO/CMO
- Strong appreciation of the impact of regulatory agencies on drug development

Required Skills for Pharmaceutical QA Auditor 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.