QA Deviation Specialist
Morris Plains (Morris County) Design / Civil engineering / Industrial engineering
Job description
Job Description
This position will be expected to work a M-F work shift. (some shifts will be 2nd Shift and may be required in the evenings and weekend) • 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.
Posting Title
QA Deviation Specialist
Desired profile
Minimum requirements
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
Job Type
Full Time
Country
USA
Work Location
Morris Plains
Functional Area
Quality
Division
Novartis Technical Operations
Business Unit
NTO BTDM
Employment Type
Regular
Company/Legal Entity
Novartis Pharmaceuticals
EEO Statement
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.