Sr. Quality Assurance Associate

Full Time, Temporary/Contract/Project, Employee Job Category: Biotech/R&D/Science Relevant Work Experience: 2+ to 5 Years Career Level: Experienced (Non-Manager) Company: Devon Consulting Contact: Steven Horner Phone: 610-964-5772 Reference Code: D8536 Sr. Quality Assurance Associate Our client located in Exon, Pa is searching for a Senior Quality Assurance Associate.Division/Department: Quality Assurance Reports to: Manager, Clinical Quality Assurance Job Summary In this position the incumbent shall independently conduct a series of detailed GCP audits of Phase I – III domestic and international clinical research trials and/or GCP-related systems and processes to assure compliance with all applicable government regulations, federal guidelines, company standard operating procedures, and industry standards. Audits will be performed on external investigator sites, vendors/CROs, trial master files (TMFs), data/CRFs, study reports, and GCP-related systems/processes for clinical trials.Essential Functions Plans, schedules, and conducts QA audits to assure adherence to company Standard Operating Procedures, and any applicable regulatory requirements.Audits clinical investigator, trial master files, system/process, document and vendor audits/assessments.Reviews audit responses for acceptability; elevates issues that are above incumbents abilities or that cannot be resolved.Recommends corrective action to compliance issues and/or observations as needed to insure corrective action is implemented.Monitors clinical operations corrective action process to insure corrective actions are being appliedWorks with supervisor to develop and maintain standard operating procedures.Provides support to management during regulatory sponsor monitor inspections, as needed.Other projects and responsibilities may be added at the company's discretion.Job Requirements and Qualifications BA/BS degree in biological sciences, nursing or related discipline, or equivalent experience requiredStrong knowledge of government regulations, guidelines and standards for investigation of new pharmaceutical products is requiredExperience in QA audits of Clinical InvestigatorsExperience in QA audits of Clinical documents associated with clinical trialsExperience in system/process auditsExperience in development of SOPsWorking knowledge and understanding of drug development and global clinical regulatory environmentAbility to manage multiple projectsEffective organizational skillsEffective team player and detail orientedStrong attention to detail, good organizational skills, ability to work independentlySolid oral and written communication skills with ability to communicate effectively and professionally with medical personnelKnowledge Requirements:Knowledge of the code of federal regulations, European Directives, ICH/GCP practices. The candidate will also have a working knowledge of clinical auditing processes. Previous participation in regulatory inspections is a plus.Experience:A minimum of 3-5 years working experience as a clinical quality assurance auditorPlease send resumes to Steven Horner at Shorner@devonconsulting.com    Find An IT Job Find A Clinical Job Click here to learn about the benefits provided to Devon Consultants