- Entry level
- No Education
- Salary to negotiate
This position provides Quality Assurance oversight of Manufacturing and Quality Control areas. Provides QA review and approval of new and existing procedures, investigation documentation, and process control documents. Uses trend and investigational data to create value through process improvements and failure reduction activities. The incumbent must act independently to identify failure modes and related process improvements, facilitating teams and working independently to implement required changes. Performs QA technical review for assigned area. Provides final QA approval on all process, cleaning, method validation protocols, reports and discrepancies, change controls, deviations, OOS investigations, complaint investigations, equipment/facilities.
• Provides first response for Quality and Compliance issues on the manufacturing floor and the laboratories.
• Provides review and approval of: Deviations, Investigations, and Inquiries; Protocols/Discrepancies (Validation, Equipment, Process, Production); Change Documentation (CCR’s, DCM’s, PAC’s.)
• Uses data trends to work with operating departments to identify process improvement opportunities.
• Drives compliance, efficiency, or process improvement projects.
• Represents QA on cross functional improvement and process monitoring teams.
• Leads and/or participates in scheduled and unscheduled audits of operational areas.
• Lead teams for tracking of quality activities, metrics, CAPA tracking, etc..
• Provides backup to Record Review for review/release of production batch records.
• May provide QA approval on any of the following: Change Control; Operational Procedures; Deviations; Lab Inquiries/OOS Investigations; Process, cleaning, validation protocols, reports and discrepancies; Process, equipment and facilities qualifications, protocols/reports; Monitoring instruments and procedures.
• Interacts closely with Quality Systems, Operations, Technical Services, Supply Chain, and Lab Management to ensure unfavorable trends are identified and resolved.
• Provides QA representation on Raw Material Issues team ensuring information continuity for incoming quality concerns through Supply Chain to vendors.
• Acts as lead or participates in internal audits of plant and laboratory operations.
• Interfaces with internal partners to resolve technical issues and initiate process improvements.
• Takes initiative to identify and solve technical and procedural deficiencies to improve productivity.
• Performs other duties as assigned.
• Receives little supervision for most assignments.
• Receives general instructions for non-standard analyses and projects.
• Interfaces to negotiate and exchange information with all levels of management.
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.
BS/BA in Chemistry, Engineering or life sciences and 5 years of professional related experience
Experience / Skills:
Experience in a GMP laboratory and/or production environment. Certifications: ASQ CQE/CQA a plus. Physical Requirements: Lifting: Infrequently lifting 25kg to waist height. Approx 25% on floor time (Walking/Standing). Limited Travel (1-5 times/yr.). Other Qualifications: (i. e. skills, knowledge) Knowledge of applicable processes, validation, investigation review. Proven ability to work in a team environment through conflict resolution and negotiations. Fundamental understanding of applied statistics. Excellent written and verbal communication skills. Adherence to all health, safety & environmental requirements in support of departmental and site HSE goals. Work in a safe and efficient manner.
This is a 3rd shift position - 11pm to 7am, Monday through Friday
Division Novartis Technical Operations
Business Unit NTO QUALITY
Site Wilson, NC
Company/Legal Entity Eon Labs Inc
Functional Area Quality
Job Type Full Time
Employment Type Regular
About the company
Novartis has a clear mission, focused strategy and strong culture, all of which we expect will support the creation of value over the long term for our company, our shareholders and society. We recognize that our business depends on the creativity, dedication and performance of our associates. We encourage associates to focus on achievement through collaboration and innovation.
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of which makes us one of the most rewarding employers in our field.
Our company culture is guided by high ethical standards. Our values help guide the choices people make every day, and they define our culture and help us execute the Novartis strategy in line with our mission and vision.