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THIS POSITION IS CONTINGENT UPON AMERICAN RECOVERY AND REINVESTMENT ACT (ARRA) FUNDING.
The Vaccine Clinical Materials Program, SAIC-Frederick, Inc. supports the Vaccine Research Center in manufacturing materials for Phase I & Phase II clinical trials. Will draft, execute, and review qualifications (IQ/OQ/PQ) of analytical instrumentation; calibrate and maintain lab equipment; apply knowledge of cGMPs and GLPs; follow good documentation practices; prepare and submit reports for review in a timely manner; perform special projects on analytical and instrument problem solving; work with lab personnel on projects as assigned and participate in out-of-specification and failure investigations; recommend possible corrective actions; review and update SOPs as needed; maintain the safety and orderliness of the lab.
REQUIRED SKILLS: Requires a Bachelors degree from an accredited college/university in a scientific discipline or 4 years experience in lieu of degree. Foreign educated candidates who have completed part or all of their education outside of the United States must have their foreign education evaluated by an SAIC-approved accrediting organization to assure that it has met the equivalency of the qualifications of degree work in the United States. In addition to educational requirements, a minimum of 2 years related experience required. Knowledge of Good Laboratory Practices (GLPs) and current Good Manufacturing Practices (cGMPs), and knowledge of laboratory environment and equipment used for pharmaceutical analyses. Ability to follow SOPs and comply with cGMPs/GLPs; effectively communicate and interact with personnel. May be required to work flexible hours including weekends and evenings and may work in a BL2 environment. This position is subject to obtaining a Public Trust Clearance.
DESIRED SKILLS: Knowledge, skill, and ability to execute analytical instrument installation, operation, and performance qualification, ability to calibrate analytical instrumentation, established ability to troubleshoot analytical instrumentation; ability to perform a variety of analyses including computer-based instrumental analytical methods.
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