QA Deviation Specialist Job in New Jersey (NJ), Laboratory Career, Full Time Jobs in Novartis Pharmaceuticals
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QA Deviation Specialist job in Morris Plains

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Novartis Pharmaceuticals jobs
New Jersey (NJ), Morris Plains
Job Code:  246492BR
Employer:  Novartis Pharmaceuticals
Category:  Laboratory
Job Type:  Full Time

Location
Country:  United States
State:  New Jersey (NJ)
City:  Morris Plains
Map: 
09/05/2018

Description
This position will be expected to work Sunday-Weds or Weds-Saturday work 1st shift. (some work may be required in the evenings and weekends) • Provides assistance to the QA Operation Batch Managers, Specialists and Associates to meet batch record review/disposition schedule in order to adhere to infusion schedule dates. • Ensure the deviation process meets Industry and Novartis expectations and requirements. Drives continuous improvement and enhancement efforts with regards to the management of Deviations to ensure an efficient yet Compliant process is maintained • Initiates, Reviews and Approves Deviations, OOSs, CAPAs, Quality Events to ensure adequate levels of documentation are adequate and compliant to existing procedures. Provides appropriate feedback as required. • Performs CAPA effectiveness checks as required. • Supports the coordination of activities associated with event resolution and CAPAs with a focus on organizing and attending cross-functional meetings to lead/facilitate investigations and to provide updates on discrepancy investigations; publish meeting minutes and action items from meetings; provide support to the investigation process and follow-up to ensure timely deviation closure. • Initiates Escalation activities as required. Participate in escalation meetings as required. • Performs trending analysis of deviations, CAPAs, OOS as required. • Supports APQR program with regards to providing analysis for deviations and CAPAs. • Supports the preparation and presentation of trend reports for Quality Management Reviews. • Implements and ensures adherence of appropriate regulations and Novartis quality standards.BS/BA in Biological Sciences or equivalent relevant career experience Fluent in speaking/writing English Minimum of 7 years GMP manufacturing and/or QA related experience, at least 2 years of which are in the area of quality assurance and/or compliance or equivalent experience. • Experience in working in Analytical Development and/or Quality Control functions. • Strong planning, execution, interpersonal, commu-nication, negotiation and problem solving skills • Strong project management skills • Considerable organization awareness (e.g. interre-lationship of departments, business priorities), in-cluding significant experience working cross-functionally and in global teams
ref: (246492BR)
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