QA Specialist II – GCP Audits

Job Description:
The QA Specialist II – 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.


Responsibilities:
Audit and provide QA support to studies performed by clinical research department, pre-clinical department and CRO: assess compliance with applicable FDA regulations, GCP, GLP, standard operating procedures and protocols; may also audit operating systems, processes and procedure review; document audit observations; make recommendations for corrective action
Critically review and audit clinical and non-clinical laboratory study documents and final reports to assure that methods are followed and observations and results are accurately recorded
Provide QA review of regulatory documentations: assess accuracy and quality of scientific data submitted to Food and Drug Administration (FDA) in support of new drug application (NDA)
Provide support when questions of compliance or interpretation of regulations arise, and recommend prospective or retrospective action plans
Prepare and/or review SOPs for pre-clinical, clinical research, and clinical QA departments
Conduct periodic QC/QA training
May create and maintain clinical quality assurance databases, reports, and files.
May act as an adviser on clinical quality assurance issues such as patient consent forms, drug accountability, adverse experience reports, and protocol amendments
Perform related duties as assigned or directed by supervisor
Anticipated travel: 20 – 25% (domestic / international)
REQUIREMENTS
Qualifications:
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
Understanding of Rx drug R&D Clinical & Clinical QA processes preferred