Our client, a growing biotechnology company, is seeking an individual to assist with validation and calibration in a Biologics/Pharmaceutical environment. The person will report to the QA Manager. The position involves supporting operations in manufacturing and laboratory testing. The successful candidate will have 3-5 years of validation experience, including setting up temperature monitoring devices such as a Kaye Validator in sterilizers, freezers, incubators and refrigerators to evaluate temperature distribution. This individual will also be experienced in Design of Experiment and demonstrate good writing skills with respect to validation protocols and reports.
Responsibilities: -Write validation protocols and reports -Write test protocols for validations as necessary -Assist with maintaining a schedule of validations; plan validations and provide notifications -Perform validations of temperature controlled equipment and sterilizers -Assist with laboratory validations by helping laboratory personnel formulate a plan -Assist with process validations by helping manufacturing personnel formulate a plan -Some calibration activities are required -Teach others in organization the importance of validation -Other tasks as assigned
Requirements: -Knowledge of cGMPs and Microsoft Office products -Bachelor s degree in science or engineering preferred -Previous experience writing validation protocols and reports, and formulating validation plans -Experienced with dataloggers such as Kaye Validator -Knowledge and experience with FDA s Guidance for Industry: Process Validation: General Principles and Practices -Knowledge of basic statistics -Well organized -Detail oriented and motivated to ensure high quality -Must be able to keep neat, legible records and work together effectively with other staff
About Kelly Services ®
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions. Kelly ® offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis. Serving clients around the globe, Kelly provides employment to more than 560,000 employees annually. Revenue in 2012 was $5.5 billion. Visit kellyservices.com and download The Talent Project , a free iPad ® app by Kelly Services.
Since employing its first engineer in 1965, the Kelly engineering specialty has grown to be recognized as a leading provider of engineering resources to customers in such industries as automotive, chemical, defense, electronics, energy, medical device and pharmaceutical.
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Kelly Services - 13 months ago
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Kelly Services, Inc. (Kelly) is a global temporary staffing provider operating in 36 countries and territories throughout the world. The...