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Company Contact Info
- Malvern, PA 19355
- Phone: 973-984-7900
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Townsend & Associates • Malvern, PA
Posted 27 days ago
Travel - None
Experience - 2 to 5 years
Degree - 4 Year Degree
Computer Software, Pharmaceutical, Other Great Industries
Admin - Clerical, Pharmaceutical, Other
Relocation - No
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- 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.
W2 ONLY!!! NO CORP TO CORP!!!
- 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.
Job ID: 17-01277
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