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Documentation Control Coordinator I
| Details |
Country: USA
Location: California-Orange County IRVINE, CA 92602
Total applied: 39 |
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Documentation Control Coordinator I
Teva Parenteral Medicines is a global leader in the manufacture of generic injectable pharmaceuticals. A member of TEVA Pharmaceuticals Industries, the world's leading manufacturer and marketer of generic drugs. The company's mission is to play a leading role in the transformation of the U.S. healthcare system through its preeminence in the development, manufacture and marketing of generic pharmaceuticals. Teva Parenteral Medicines has an excellent opportunity for Documenation Control Coordinator I. Generation/issuance/revision of documenation to meet weekly production schedule. Continuous awareness of the status/location of in-process documentation, and follow up with internal customers to ensure a timely turnaround of documents. Generation/maintenance of reports indicatingstatus of in-process and issued documentation. Responsibilities: * Accurate creation/revision (routine) and timely issuance of documentation (batch records, SOPs, and/or MCAs) as required by the weekly production schedule and internal turnaround times. * Maintain/update Documentation Control/Product Tracking databases to ensure proper tracking of all SOPs and/or MCAs in the routing/approval process and batch record issuance. * Coordinate with Documentation Control supervisor to ensure that all MCAs/SOPs affecting the production schedule are completed prior to issuance of the batch records. * Responsible for the issuance of all logbooks, archiving all logbooks, maintenance of logbooks, and updating Logbook Tracking database. * Generate Transmittal letters and maintain annual manual audits for our customers. * Generate "Annual Product Review" reports for QA on a monthly basis. Generate MCA history packets for Regulatory upon request. * Maintain and/or coordinate all Documentation Control active and archived files so that they are appropriately filed, labeled, stored and accessible. * Follows Teva Safety, Health, and Environmental policies and procedures. Complete all TevaU training assignments within the designated time of one week. * Other duties, as assigned, or as business needs require. Primary Outcomes: * Applies job skills, and company policies and procedures to complete a variety of tasks. * Works on assignments that are semi-routine in nature, where ability to recognize deviation from accepted practice is required. * Normally receives general instructions on routine work, and detailed instructions on new assignments. Qualifications: * Education Required: High School Diploma/GED * Experience Required: Minimum of 1 year related experience As a member of TEVA Pharmaceutical Industries, Ltd., the world's leading manufacturer and marketer of generic drugs, we regularly seek dedicated and hardworking professionals with the necessary skills for our business. Teva Parenteral Medicines offers a comprehensive benefit package, including major medical, dental, vision, 401(k) and the opportunity to grow with a dynamic company. For immediate consideration, please visit www.tevausa.com Click Employment Opportunities, then Positions Available and search for Position # 08-2938. No relocation is offered for the position. Only local candidates will be considered. Resumes will be reviewed and qualified candidates will be contacted for pre-screening. To Apply for this position, please CLICK HERE
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