SQAFYI - Software QA Resource - FYI

US-Durham: Quality Assurance Associate

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Date: 24-Sep-2010

Quality Assurance Associate

This position will be graded as a Specialist I, Specialist II, or Quality Assurance Associate based upon the skill and experience level of the candidate. • Strong knowledge of the clinical trial process, GCP regulations, and ISO 9001 requirements. EDC, SDLC, software validation, and/or eClinical knowledge is a plus. • At least three years experience working in a CRO, pharmaceutical, medical device, biologics and/or biotech Quality or Regulatory Compliance organization. • Associates or higher degree in a related field, or five years of scientific, medical or applicable experience related to PharmaLink’s business areas. Alternatively, a minimum of three years of direct PharmaLink experience as project assistant, project coordinator, research assistant or Quality Control Auditor may be substituted for the degree requirement. • Good interpersonal skills. Experience working with various levels of personnel; specifically senior management and outside clients. • Proficiency in word processing software, PowerPoint, Microsoft Access, and exposure/experience with EDC systems. • Working knowledge of quality assurance auditing, to include ISO, GCP, and general good business practices. • Knowledge of general principles of document management systems. • Excellent technical writing skills and fine attention to details, to include composition, grammar, punctuation and spelling. • Good communication skills, both written and verbal, with all levels of staff, clients, and with the public. • Good organization and time management skills • Working knowledge of MS Word, Excel, PowerPoint, and Access • Knowledge of Windows environment and the Internet.

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Thank you,
Team SQAFYI - Software QA Resource FYI

US-Durham: Quality Assurance Associate