To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #03030

About our client Our client is a CRO servicing the medical device, pharmaceutical and biotech industries. The company has strong financials, an experienced management team and a loyal customer base. They have developed an industry-wide reputation for a positive work environment and an aggressive training program that ensures employees are up to date on current trends and best practices. This is a strong opportunity for someone that wants to put their drive and initiative to work. Position Location Quality Systems Auditor Southern California Salary Highly competitive package, commensurate with experience Responsibilities 1) Participate in reviewing corrective actions (as required) 2) Represent QA on sponsor/project teams under the direction of QMS Manager 3) Advise/communicate to QMS Manager the need for audits of PMI systems 4) Develop a working knowledge of current GCP regulations, guidelines and related auditing techniques 5) Assist in the conduct of sponsor audits and mock regulatory inspections 6) Provide inputs for interpretation of regulations, guidelines, corporate standards and policies 7) Plan, conduct and report Quality System audits (as scheduled) 8) Assist with and document audits of QA policies in accordance with written audit plans to check for adherence to the Quality System 9) Assist with requested reviews of project-related and non-project-related work products to check for adherence to SOPs 10) Prepare regular written and oral status reports for QMS Manager 11) Gather trend analysis of audit results as well as provide QMS Manager with initial root cause analysis 12) Ensure that the Quality Assurance System is maintained in accordance with current regulations (FDA, ICH and ISO) 13) Ensure that QA policies (SOPs) are maintained in accordance with current regulations (FDA, ICH and ISO) 14) Perform other related duties as assigned 15) Host sponsor audits (as needed) 16) Work with concerned parties to prepare corrective action plan (as applicable) Requirements 1) BS/BA 2) Minimum 2 – 3 years of related QA experience in the pharmaceutical, device, biotech or CRO industry 3) Experience in Quality System processes and procedures 4) Understanding of FDA regulations regarding conduct of clinical studies, procurement of informed consent and IRB responsibilities 5) In-depth understanding of Good Clinical Practice 6) Ability to work in varied environments 7) Ability to lift, pack and carry study materials as well as stand for filing, copying, faxing and collation of study materials 8) Willingness to travel (air or ground transport)