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Apply online for the
GXP Document Compliance Specialist II
position and advance your career in the
Biotech industry today.
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GXP Document Compliance Specialist II : MedImmune, LLC.
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| Job Number |
02230 |
| Employee Type |
Full Time |
| Company Name |
MedImmune, LLC. |
| Location |
Gaithersburg
Maryland
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| Salary (year) |
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| Start Date |
2/9/2010 |
| Industry |
Biotech |
| Job Type |
Operations |
| Relocation |
Not Required |
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| Description |
Description
Title: GXP Document Compliance Specialist II
Location: MD, Gaithersburg - Corporate Headquarters
Req: 02230
Position Summary:
Maintain document tracking system, issue and track document distribution, and audit document manuals as required. Work on assignments that are moderately complex in nature where judgment is required
Essential Job Functions:
• Maintain document tracking system, issue and track document distribution, and audit document manuals as required.
• Process Change Requests, review documents for format and grammar, and perform minor edits.
• Performs review of each document submitted for change/review to ensure compliance with existing procedures identifies affected documentation and defines appropriate action.
• Maintain document archive via EDMS System (electronic) and storage of hard copy documents
• Support archive users by performing database searches, file retrieval and photocopying as needed.
• Perform EDMS training for R&D and Clinical
• Scanning of Internal and external audits
• Write and revise SOP’s
About the Organization
My company shares my
passion for helping to improve human health around the world."
"This is My MedImmune."
Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc.
Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities…that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world.
Company Information
MedImmune, LLC. is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.
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| Requirements |
Position Requirements
Physical Demands:
Noise level: Quiet
Vision Requirements: Ability To Adjust Focus
Lifting Limits: Up to 25 lbs
Work Environment:
Percentage of Time:
Standing: 0 - 25%
Walking: 0 - 25%
Sitting: 76-100%
Hand Use: 76-100%
Stooping or Crouching: 0 - 25%
Talking and Hearing: 51-75%
Title: Document Complience Sepcilist II
FLSA: Non Exempt
Date: 10Nov08
Knowledge:
Full knowledge of the job. Substantial acquaintance with and understanding of general aspects of the job with a broad understanding of the detailed aspects of the job.
Discretion / Latitude:
General supervision and instructions given for routine work and detailed instructions given for new activities or special assignments.
Impact:
Errors can be detected and corrected but may cause moderate loss of time or customer/user dissatisfaction.
Liaison:
Contacts are typically with individuals within own department and occasionally with contacts outside own organization. Contacts involve obtaining or providing information or data requiring some explanation or interpretation.
Educational Requirements
Typical Education:
Bachelors: Business Administration or Life Sciences
Typical Experience:
3-5 years experience
Certificates, Licenses, Registrations:
N/A
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