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Title : MKA- Quality Auditor - Scientific - III (Senior) -472
State : North Carolina   Date : Mar 14, 2019
Experience Level :  
Position Type : Quality Auditor - Scientific - III (Senior)      
Description
This position is for a leading pharmaceutical company. Below are the details of the engagement. If you are available and interested please send me your updated word resume & your expected hourly rate on W2 ASAP.
Looking forward to hearing from you soon.

Work Location: Durham, NC


Job Title: Quality Auditor - Scientific - III (Senior)


Duration:  6+ months (extendable) contract on W2


Duties:


Batch records or logbooks reviewers more tailored towards Quality Assurance. Candidate should have some exposure to technical based decision making in pharma. Under the direction of GMPQ supervision, the Auditor conducts routine audits of data, information, procedures, equipment and systems (including computer systems), and/or facilities to ensure the compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) and other applicable worldwide regulations. Review and approve production and analytical documentation accompanying the release of API, Safety Assessment or clinical supply lots (bulk and packaged) to ensure conformance to appropriate regulatory requirements. In addition, the Auditor communicates and resolves audit comments with client areas. Under supervision, or as part of a team, perform audits or inspections of assigned areas or systems to assess compliance with regulatory and client standards. Issue reports summarizing deficiencies and work with areas to execute remedial action. Notify appropriate management of inspection results.


 
Skills:


Effective communications (oral/written) and interpersonal skills are necessary.Experience with release process, deviations and quality systems including Change Control Management and validation. Experience Environmental monitoring. Individual must be able to Aseptically Gown and remain on the shopfloor for a minimum of 4 hours.



Education:



B.S. in an appropriate Science or Engineering discipline. Minimum of 4 years of quality assurance experience required with a B.S. Experience should be in the pharmaceutical/chemical industry or government drug-regulatory agency with a working knowledge of cGMP regulations.


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Many Thanks,   

Sree Kanth
Recruitment Manager
Sree@newageclinical.com

NewAgeSys, Inc.
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Princeton , NJ 08540 
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