Job Description
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Title
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Sr Validation Coordinator
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This is the short description for the job opening. |
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Location
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Alameda, CA
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This is where the job is located |
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Job Description
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Develops validation master plans and coordinates the completion of the validation activities in the plans. Involved in the validation of methods for the production, purification, and testing of new formulations. Involved in new product scale-up, process optimization, technology transfer, and process evaluation activities. Involved in the validation of facilities and equipment used in the test methods and manufacturing processes. Advises on projects of diverse scope where analysis of data requires evaluation of identifiable factors. Provides validation expertise during the development of production procedures and product specifications. Maintains substantial knowledge of state-of-the-art validation principles and theories. Reviews changes to equipment, facilities, and processes for validation requirements. Uses professional concepts and company policies and procedures to solve a wide range of difficult problems in imaginative and practical ways. Serves as in-house and outside consultant.
Requires knowledge and skills normally acquired through the successful completion of a of a Bachelors, Masters or Doctorate Degree (B.S./M.S./Ph.D.) in Chemistry, Biochemistry or related scientific discipline, with 5 - 7 years of experience managing validation activities and supervising or coordinating personnel in the validation function of a medical device, pharmaceutical or life science company. Knowledge of LIMS helpful. Experience in a FDA regulated environment and knowledge of QSR requirements for validation, mandatory. Requires knowledge and skill in the use of common and specialized laboratory equipment and safe chemical handling. Sufficient technical skills to manage projects of a diverse and highly complex nature. Requires excellent communication, organizational and interpersonal skills. Familiarity with related analytical instrumentation or technology required.
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Please describe the job you are offering. Do not include your company name or contact information here. Applicants respond by submitting their resumes. |
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Salary Range
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$65K-$90K
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What salary range were you considering for this position? |
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First Question
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How many years of test methods and process validation do you methods and have?
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This is used to prioritize the candidates. You might ask years of experience with your technology. |
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Second Question
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How much verification and validation of software and equipment do you have?
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This is used to prioritize the candidates. You might ask years of experience in your industry. |
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Market Place
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North America
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The marketplace defines the visa requirements. Please let us know which market this job is in. |
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Employee Or Consultant
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Either
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Are you looking for an employee or a consultant? |
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Service Type
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Free Email Announcement
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