US-TX, Sr. QA Analyst I - QA Operations 233360BR-MZ
Sr. QA Analyst I - QA Operations
Novartis Technical Operations
Fort Worth, TX
Alcon Research, Ltd.
Act as Sr. QA Analyst I by assuring products manufactured are in compliance with corporate, regulatory and industry standards through oversight of operational documentation and routine quality inspections. Make critical decisions on issues that affect product quality and determine disposition of product. Facilitate tier board meetings, track key quality metrics and present updates to site management. Ensure continual process improvements within operations to drive reduction of deviations and improve process throughput. Lead routine and non-routine production support activities to include Change Control, Validation, Investigations, CAPA.
Subject matter expert on QA Shop Floor Operations including SOP s ,QA Audits, Documentation Review / Retention
Coordinate the daily shop floor tasks for the specified shift to ensure that production lines operate according to applicable SOPs, quality standards, and defined production schedules
Implementation of local quality systems that comply with standards and regulatory requirements
Review and approve critical alarms
Assist in smoke studies, media program and other validation/compliance activities in the aseptic areas
Review and approve sterility break request forms
Oversight of validation, projects and change control
Assure that products and processes comply with market authorization, drug application or regulatory requirements.
Assure GMP requirements/compliance are adhered
Approval and rejection of procedures, limits, specifications impacting on the identity, strength, quality, and purity of the product
A thorough understanding of all aspects of the manufacturing facility, process, procedures, and equipment is required. May receive technical guidance on complex problems, but independently determines and develops approaches and solutions.
Participate in internal and external audits.
Author, review and approve documents online
Maintain computerized systems Inventory for Automated systems
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.
Bachelor's degree with 2 years experience or High School with 10 years exp. Preferred: Bachelor of Science in Biology, Microbiology, Chemistry, Biochemistry, Engineering, with 5+ years experience English Min: 2 years exp. Preferred: Bachelor of Science in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field. 5+ years combined experience in pharmaceutical, Medical Device or Biotechnology Industries, including experience with Root Cause investigation, Statistical analysis, Regulatory compliance understanding, Regulatory audit experience, Lean Six Sigma, Computerized System Knowledge, Product and Process Validation.
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