QA for QC Specialist

Job description

Job Description

Support quality systems and programs for new product transfers, process validation. Provide QA oversite for QC ( review/approved test records, SOP’s, C of A’s Deviations, CAPA’s protocol and reports related to QC labs Providers the QC team with QA/Compliance guidance and decisions Reviews/Approve documentation associated with a given product Reviews and approves method validation protocol and reports Reviews and approves QC related documents for batch record disposition Support activities associated with event resolution and CAPAs. Performs independent quality evaluation of investigational reports including root cause analysis cause/preventive action identification, CAPA effectiveness check and trending. Implementation and ensures adherence of appropriate regulations and quality standards. Write, review and approve Standard Operating Procedures (SOPs), Quality Risk Assessments (QRAs), Quality Plans, and specifications, as needed. Review and approve technical reports, validation protocols and reports as needed. Review and approve trend reports (environmental, product, OOS, OOE, reference/control, etc) Support training program for QC analysts for lab specific quality systems and compliance Support continues quality improvement program for QC laboratory and partner with the QC team to implement/optimizes to improve efficiency (right the first time) and monitor/escalate as needed. Support QC self-inspections Prepare and participate to health authorities inspections and internal audits to present QC quality systems Support regulatory filings. Provide cGMP and associated OJT training to QC Perform or support any other tasks necessary to maintain the product quality and site cGMP compliance, as needed.
Posting Title

QA for QC Specialist

Desired profile

Minimum requirements

MSc or BS in Pharmacy, Biotechnology, or Chemistry English fluent in speaking and writing. MS or equiv: 4 years’ QA related experience with 2-3+ years in lab related , or, BS: 6+ years QA related experience with 3+ years in lab related Related experience should be in GMP-regulated industries in quality assurance and/or compliance or equivalent experience. Related experience in supporting an operational quality control lab. Must have a working knowledge of regulatory (FDA, EMEA Etc.,,) requirements as well as industry quality management tools, standard, and quality systems. Must have an understanding of pharmaceutical industry trends and practices. Broad cGMP experience is required with knowledge and understanding of manufacturing, quality control, and validation requirements and activities.
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.