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Research Operations Manager Job
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| Employer Name: BiotechCrossing |
SpiderID: 2298680 |
| Location: Thousand Oaks, California |
Date Posted: 6/20/2008 |
| Wage: |
Category: Biotech |
| Job Code: 5392016 |
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Job Description:
Primary responsibilities include supporting the regulated CBSS roles in the creation, revision, and review of their current business processes as well as participating as the CBSS representative on overarching documents which include CBSS staff in their scope. For CBSS GLP regulated documents, this role will coordinate the document review and approval process in Amgen's document management system. In addition, the successful candidate will track GLP regulated staff compliance with required training and support them in meeting their required training objectives. The successful candidate will contribute to the communication of compliance related information using tools such as the CBSS Newsletter, the CBSS internal web community, quarterly managment report, etc. The successful candidate will also contribute on CBSS' inspection related activities by: managing the CBSS inspection binder, representing CBSS as the department contact on external inspections, coordinating internal facility inspections, tracking to completion any inspection related commitments, and any other compliance related support activities as identified.In order to adequately meet the expectations of this role the succesful candidate will be a CBSS coordinator for the following Amgen systems: Audit Managment System (AMS), SOP Management System, ALERT Find (communication tool) and the Learning Management System (LMS) (a back-up to the Training Coodinator). Requirements Bachelor's degree in Life Sciences. A minimum of 3 years Good Laboratory Practices (GLP) study managment or study auditing experience in the biotech/pharmaceutical industry.Preferred Qualifications:Working knowledge of 21 CFR Part 58. Five to seven years of drug development knowledge with primary awareness in the following functional areas: Compliance, preclinical or research development. Minimum two years experience in a local system administrator or business process expert role. Minimum four years experience in writing or supporting Authors in the creation or revision of governance documents. Proven experience in mapping business processes. Ability to apply project management tools and timeline management to achieve results. Effective verbal and written communication skills combined with strong project coordinator and electronic tools proficiency
For more information, please click here To visit us at BiotechCrossing.
For further information, please visit us online at http://www.biotechcrossing.com
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Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: - |
Company Type: Employer |
| Company: BiotechCrossing |
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| City: Pasadena |
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| State: California |
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| Zip: 91101 |
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Web Site: http://www.biotechcrossing.com
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