US-TX, QA Analyst I - Shop Floor Support (12-hr. Rotating Shift - Days) 237721BR-MZ
QA Analyst I - Shop Floor Support (12-hr. Rotating Shift - Days)
Novartis Technical Operations
Fort Worth, TX
Alcon Research, Ltd.
**This position is a 12-hr. rotating shift crew schedules on Day Shift**
Safety/Housekeeping Ensure work areas comply with applicable standards (HSE, GMP, etc.).
Promote/reinforce company and department HSE standards, through regular communication, training, and reminders.
Consistently exhibit safe behaviors and wear proper PPE.
Ensure work areas are clean and safe, and audit-ready at all times.
Continuously monitor work areas; identify, resolve, and report safety hazards.
Ensure materials are handled and disposed of properly, per HSE standards.
Planning Ensure precise planning related to production schedules and compliance activities
Plan and schedule work activities based on production schedules, product release needs, media program, shutdown activities and changing priorities.
Responsible for contributing to meet group deadlines.
Contributes in the Tier Board meetings and keeps metrics up to date.
Assure training and qualifications are current.
Technical Ensure products comply with applicable standards.
Ensure that products are manufactured to appropriate cGMP standards by reviewing all deviations related to all processes within operations, including compounding, filling, packaging and product release.
Provide guidance to production and maintenance groups on intervention recovery methods in the aseptic areas.
Review critical alarms assessments and assist with investigations as necessary.
Author, review and approve QA documents and procedures.
Assist in smoke studies, media program and other validation/compliance activities in the aseptic areas.
Review and approve sterility break request forms.
Team Cooperate with QA and Operations team to manufacture product that is high in quality and meets all regulatory and company requirements
Take ownership and contribute to solving problems. Drive projects to completion ahead of deadlines.
Proactively share critical expertise and help individuals understand their role in the group.
Build relationships within QA and with other departments to help achieve business goals.
Demonstrate overtime flexibility for production needs.
Exhibit company values and behaviors.
Interfaces Coordinate with and support other departments to ensure smooth execution of work.
Work cohesively with Production and other departments to resolve issues in order to release quality product.
Work with Technical Support and Complaint teams to find true root cause and implement effective corrective actions.
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.
Minimum: Bachelor's Degree (preferably in Science or Engineering) or equivalent combination of education and relevant experience
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