QA Specialist - GCP Audits

QA Specialist ? GCP Audits

 

Endo Pharmaceuticals Inc. is a fully integrated, independent pharmaceutical company with market leadership in pain management products.  Our sustained rapid growth in both branded and high-value generic products continues to create exciting opportunities.  We are currently seeking a highly motivated individual to fill a QA Specialist position in our Chadds Ford, PA office

 

Summary:

The QA Specialist ? GCP Audits, reporting to the Assoc Dir, QA Clinical, is a member of the Quality Assurance team with responsibility for working with clinical research partners in support of development products.  The QA Specialist will participate in cross-functional research support teams.

Primary responsibilities include but are not limited to: performing quality assurance audits of investigational study sites, laboratories, clinical study reports, protocols, clinical processes, data and vendors to assure compliance with Federal Regulations, Good Clinical Practices (GCP) and Good Laboratory Practices (GLP);  assisting in the development, training and management of Standard Operating Procedures (SOPs);  preparing and conducting GXP training;  performing internal assessments and audits to assure compliance with appropriate regulations, guidelines and company policies and procedures.

 

Requirements:

?  Healthcare degree preferred (BS nursing, RPh, PA) preferred, BA or BS in science ? understand scientific concepts and methods; ability to perform complex analysis of scientific data; ability to assess investigational site compliance, develop reports & present conclusions; critical thinking skills; strong oral and written communications skills

?  Five to eight years experience in pharmaceutical development: ability to independently plan and coordinate audits/co-audits, assess accuracy and quality of scientific data; ability to audit processes and procedures; ability to audit a variety of venues including clinical sites, clinical supply manufacturers and labelers; solid knowledge of GCPs, FDA regulations and guidances and ICH guidelines relevant to a pharmaceutical clinical R&D.  Familiarity with GLP regulations

?  Experience conducting/coordinating training programs

?  Experience in the pharmaceutical industry and familiarity with the operations, business needs, organizational structure, functional roles and responsibilities, pharmaceutical/medical terminology, regulatory requirements, traditional projects and problems.

?  Experience implementing and evaluating contracted work with vendors and suppliers and maintaining cooperative partnerships

?  Project management skills and experience: assess trade-offs and synergies among projects to determine priorities; present recommendations; sequence work; identify cross-functional needs; drive to completion; provide reports; evaluate results.

?  Ability to write technical reports and critically review reports written by others: skill in the use of Microsoft Office products including Word and Excel

?  Strong interpersonal skills including ability to communicate effectively & non-confrontationally with people individually and groups; ability to communicate with technical and non-technical colleagues; experience establishing and maintaining effective relationships with leaders and peers

?  Ability to lead, manage and participate on interdisciplinary teams with shared responsibility for outcomes and decision-making and ability to manage and lead meetings; ability to balance the needs of the different disciplines

?  Willingness to travel to clinical investigational sites, clinical manufacturing and packaging sites 

Preferred:

?  Understanding of Rx drug R&D Clinical & Clinical QA processes; 

 

We offer a competitive salary and full benefits package, including medical/dental, paid vacations and a 40l(k) plan. 

 

Endo Pharmaceuticals Inc. recognizes the advantages of a diverse workforce achieved through a commitment to equal employment opportunities.

 

For immediate consideration, please send a copy of your resume to recruiting@endo.com .  Please reference QA Specialist ? GCP Audits in the subject line. 

 

Visit our web site www.Endo.com