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Batch Records Reviewer  

Contract
DESCRIPTION
A Batch Records Reviewer is needed as primary reviewer and approver for batch records and change control documents. The Reviewer will be responsible for reviewing Manufacturing and Packaging records to insure that the information and documentation conforms to policy and cGMP's and all other applicable regulatory guidelines. The consultant will enter data into the CLV2 and Lot Review Tracking (LRT) system. The Reviewer must have the ability to work under challenging work load requirements and meet deadlines to support lean initiatives. They will be a team player with excellent communication skills to facilitate completion requests and review from all levels.

Qualifications:
  • High school diploma
  • Excellent math skills
  • Ability for attention to detail and accuracy, and an aptitude for computerized systems
  • Must have good written and oral communication skills
  • Ability to handle changing deadlines
  • Must be able to follow written and verbal directions and properly handle confidential documents
  • Knowledge of GMP requirements, Record Retention process, and familiarity with standard operating procedures preferred
  • Must be self motivated and willing to learn new and changing responsibilities
  • Must possess flexibility to respond to constantly changing conditions and priorities

SKILLS
Good Manufacturing Practices (GMP), high school diploma, excellent math skills

Synectics offers competitive salaries and a full suite of benefits. EOE.

LocationKalamazoo, MI
CountryUnited States of America
Employment BusinessSynectics
ContactSynectics
Web Linkhttp://www.synectics.com
ReferenceJS 5B2CE-SY##
Posted Date05/25/2011 22:34:48
 
 
 
 
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