US-Durham: Quality Assurance Associate
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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 PharmaLinks 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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Team SQAFYI - Software QA Resource FYI