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Title : MKg- Quality Auditor - Scientific - I -821
State : Pennsylvania   Date : Aug 5, 2020
Experience Level :  
Position Type : Quality Auditor - Scientific - I      
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: West Point, PA

Job Title: Quality Auditor - Scientific - I

Duration: 12+ months (extendable) contract on W2


Duties: 

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 the Client standards. Issue reports summarizing deficiencies and work with areas to execute remedial action. Notify appropriate management of inspection results. - "A day in the life of" - In the morning, the team will start with a group meeting to discuss batch review documents. The team is then released to perform batch record review with a goal of performing 1 batch record review per day. Escalate as needed. Team will also perform electronic log book reviews and will support offsite team by providing documentation, copies, etc. Collaborative team style; communication is key to ensure timelines are met and that each team member is pulling their weight and goals are being met. No non-local candidates, please.

Qualifications: 

B.S. and/or M.S. in an appropriate Science or Engineering discipline. Minimum of 1 year of 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/GNP & GLP regulations. Effective communications (oral/written) and interpersonal skills are necessary. Documentation review systems experience, Batch record review, logbook experience, electronic record review and material disposition experience. 

Knowledge of technologies such as LIMS, SAP & TrackWise is very helpful. Vaccine manufacturing knowledge, lab/manufacturing experience, prior gowning procedures and clean room experience. Personality match - Someone whom can work with tight deadlines, good at multitasking, organized, must be a team player, however, able to stay focused and able to work on their own; a go getter. A great communicator! Education: BA/BS Chemistry/Biology.



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Many Thanks,   

Sree Kanth
Recruitment Manager
Sree@newageclinical.com

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