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Quality Assurance Specialist - Bioanalytical

Kyowa Hakko Kirin Ca, Inc.

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Location: La Jolla, CA Posted Date: 4/18/2013 Position Type: Full time Job Code: 007 Required Education: Bachelors Degree Areas of Expertise Desired: Bioanalytical Services
Quality Assurance
Validation

Description

Summary: QA Specialist is responsible for implementing, managing, and directing the Quality Assurance Program for a Laboratory that provides bioanalytical services including sample management, method development, method validation, and clinical sample analysis.  The position has oversight of key functional, strategic, tactical, and operational aspects of Quality Assurance.
Essential Duties and Responsibilities include the following, (other duties may be assigned.):
•   Manage and maintain QA systems including: change control, deviation program, and training records, etc.
•   Manage and maintain CAPA program to ensure timely implementation and effectiveness of corrective actions.
•   Review and/or develop standard operating procedures (SOP’s) for new and existing practices.
•   Perform internal/external audits of a technical discipline to verify conformance to applicable SOPs and regulatory requirements.
•   Perform protocol, data, report, and in-lab phase inspections in a technical discipline to verify conformance to applicable SOPs and regulatory requirements.
•   Perform and/or assist with laboratory investigation.
•   Assist and/or host during regulatory inspections or second party audits.
•   Evaluate responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution.
•   Monitor regulatory and industry trends/actions of quality/compliance and report regularly to management.
•   Maintain a working knowledge about government and industry guidelines, codes and regulations pertaining to GLP regulations and other applicable regulations (e.g. GCP, and relevant ICH guidelines), SOP requirements, and other guidance documents.  
•   Mentor and/or train CAD members and affiliate employees with interpretation of regulatory requirements as needed.
•   Recommend and implement modifications of existing quality standards to achieve optimum quality within limits of facility capability.
•   Provide operational, scientific and regulatory input as required.
•   Interface with team members, sponsor and/or other affiliate groups in problem resolution, and continual improvement.
•   Participate effectively in a leadership or membership role for both corporate, global and site cross-functional teams as a representative of Quality Assurance.
•   Submit quality report to management and/or parent company.

Requirements

Education and/or Experience:                  
•   BS or MS in related discipline, and 2-8 years of experience in the field or in a related area; or equivalent combination of education and experience.
•   Strong Quality Assurance experience (preferably in a FDA-regulated bioanalytical laboratory setting such as clinical PK or TK)
•   Previous technical laboratory experience preferred
•   GLP knowledge
•   Experience with GLP/GCP/ICH guidelines relating to conducting clinical trials
•   Experience with report writing and review for FDA regulatory submissions
•   Experience in report writing and review; minimum one year

Language Skills:                         
•   Ability to write, read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.  
•   Ability to write reports, business correspondence, and procedure manuals.  
•   Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Mathematical Ability:                            
•   Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.  
•   Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Reasoning Ability:                            
•   Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
•   Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Computer Skills:                     
•   To perform this job successfully, an individual should have technological proficiency for use of the personal computer, Microsoft Office Suite, and the Internet.
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