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Compliance Assistant

Townsend & Associates • Malvern, PA

Posted 25 days ago

Job Snapshot

Contractor
Travel - None
Experience - 2 to 5 years
Degree - 4 Year Degree
Computer Software, Pharmaceutical, Other Great Industries
Admin - Clerical, Pharmaceutical, Other
Relocation - No
30

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Job Description

Compliance Assistant
 
Responsibilities:
  • Support the maintenance of all Good Manufacturing Practice (GMP)/European Union documentation related to the packaging of clinical investigational product.
  • Maintain and distribute control of master batch records, protocol specific product information files, and production batch records, including the transport across campus thereof, and study information file creation.
  • Scan executed batch records and other GMP documentation.
  • Complete batch documentation history.
  • Archive Clinical Supply Chain Operations GMP documentation.
  • Participate in projects related to the production scheduling group.
  • Assist in supporting the Department during internal and external regulatory audits.


Compliance Assistant
 

Job Requirements

Compliance Assistant
 

W2 ONLY!!!  NO CORP TO CORP!!!



Qualifications:
  • Bachelor’s Degree in Business Administration or a minimum of 3 years’ cumulative experience working in a GMP/EU regulated environment required. 
  • Computer skills in Microsoft Office Suite and scanning required. 
  • Records management and organizing and maintaining a secure file/documentation room background.
  • Experience in a records management capacity handling technical or regulated GMP documents is highly desirable (specifically, technical documents, batch records, and/or standard operating procedures). 
  • Document management system or archiving software desirable.


Compliance Assistant
 




Job ID: 17-01277
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