Senior Clinical Quality Assurance Specialist

Job title:   Senior Clinical Quality Assurance Specialist   

Location: Exton, PA

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 conducted by Morphotek, Inc.

 

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 applied

· Works 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 required

· Strong knowledge of government regulations, guidelines and standards for investigation of new pharmaceutical products is required

· Experience in QA audits of Clinical Investigators

· Experience in QA audits of  Clinical documents associated with clinical trials

· Experience in system/process audits

· Experience in development of SOPs

· Working knowledge and understanding of drug development and global clinical regulatory environment

· Ability to manage multiple projects

· Effective organizational skills

· Effective team player and detail oriented

· Strong attention to detail, good organizational skills, ability to work independently

· Solid oral and written communication skills with ability to communicate effectively and professionally with medical personnel

 

Knowledge 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 auditor.

Other Information

Special Information (Travel required, physical requirements, on-call schedules, and etc.):

· Travel 25-35%



 

Morphotek Inc., a U.S. subsidiary of Eisai Co., Ltd., was acquired by Eisai in April 2007.  Founded in 2000 and located in Exton, Pennsylvania, Morphotek is a biopharmaceutical company which discovers and develops monoclonal antibodies through the use of proprietary human antibody technology called Human MORPHODOMA®. Morphotek has assembled a strong pipeline of lead products in the areas of oncology and inflammation and infectious diseases. It has programs in clinical development and in preclinical stage moving towards IND filing. For further information, visit www.morphotek.com. 

 

Interested candidates are invited to submit a resume along with specific salary requirements to mail to: jobs@morphotek.com .  Only candidates providing specific salary requirements will be considered.  Morphotek offers a competitive salary and comprehensive benefits that are considered number one in the industry.  Morphotek, Inc. is an equal opportunity employer.