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QUALITY ASSURANCE ASSOCIATE- 2ND SHIFT

Cambridge Major Laboratories, Inc.

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 Job Snapshot
Location : 
W132 N10550 Grant Drive
Germantown, WI 53022 (map it!Map it!)
Employee Type : 
Full-Time
Industry : 
Pharmaceutical
Manages Others : 
No
Job Type : 
Manufacturing
QA - Quality Control
Education : 
4 Year Degree
Experience : 
At least 1 year(s)
Post Date : 
4/30/2013
 Description

 

Specific responsibilities to this position

 

  • Review of executed Batch Production Records / Batch Cleaning Records
  • Generation of protocols and final reports as assigned
  • Revision and routing of Standard Operating Procedures (SOPs)
  •  Understand and interpret analytical data
  • Conduct analytical data review and release(raw materials, cleaning, stability, in-process, release, reference standard, validation)
  • Maintain proper document archival
  •  Perform Internal and / or external auditing
  • Adhere to training requirements and maintain training file.  Review of all documentation associated with the release of reference standards, raw materials, intermediates, and final products for use in GMP production
  • Generation of labels and Certificates of Analysis (COAs)
  • Review and routing of test methods and specifications related to GMP operations
  • Facilitate shipment of GMP Intermediates and APIs
  • Work on special projects assigned by Department Head(s).
  • Request, utilize, review, and route change controls
  • Manage and track projects assigned by supervisor
  • Facilitate ongoing improvement of processes to enhance overall quality
 Requirements

 

  • Requires four-year degree (BS) in a science discipline or a four-year degree plus a minimum of 1 year of quality or analytical experience preferably in an FDA regulated environment.
  • Must be able to work 2nd shift









                                                                                                                                                                                
Key words:  Quality, Analytical, Quality Assurance
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