QA Specialist, Operations

Job description

Job Description

THIS POSITION WILL BE FROM WEDS-SUNDAY, FIRST SHIFT
• Reviews documentation associated with a given product • Coordinates and performs batch record disposition for internally manufactured products. • Reviews and approves manufacturing and QC related documents for batch record disposition. • Reviews and approves deviations, CAPA’s, change controls, facility Work Orders, Product Specifications and any other site/product related documents ensuring adequate levels of documentation are adequate and compliant to existing procedures • Coordinates 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 notes and action items from meetings; provide support to the investigation process and follow-up to assure timely discrepancy closure. • Performs independent quality evaluation of investigational reports including root cause analysis cause/preventive action identification, CAPA effectiveness check and trending. • Develops meaningful site KPI’s and prepares and presents trend reports for Quality Management Reviews. • Implementation and ensures adherence of appropriate regulations and quality standards. • Write, review and approve Standard Operating Procedures (SOPs), Quality Risk Assessments (QRAs), specifications, Batch Production Documents (BPDs) or Manufacturing Production Documents (MPDs), as needed. • Present systems and provide documentation for self-inspections and external audits. • Interact with FDA, partner and supplier auditors/inspectors as needed. • Support regulatory filings. • Provide cGMP and associated OJT training to QA and other departments to improve right the first time (RTFT), high quality performance. • Control costs within department to meet budget. • Represent QA at corporate and site operational and cross-functional meetings, providing QA input and disseminating information back to QA as needed. • Complete job-related training in electronic database system along with GMP, safety, and Ethics & Compliance course requirements. • Perform or support any other tasks necessary to maintain the product quality and site cGMP compliance, as needed.
Posting Title

QA Specialist, Operations

Desired profile

Minimum requirements

BS/BA in Biological Sciences or equivalent relevant career experience English Minimum of 5 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
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.