Principal QC Analyst - AS&T Chemistry

  • Company: Alcon
  • Location: Fort Worth, Texas
  • Posted: December 22, 2017
  • Reference ID: 230626BR
Using in-depth knowledge of relevant guidance/regulatory documents, perform and lead routine and non-routine testing activities to include product/process investigations that ensure required quality and safety standards are being met for our products and processes.

Safety/Housekeeping - Keep work areas clean and free of hazards or dangerous conditions
• Perform laboratory housekeeping
• Follow all laboratory safety regulations, and promote positive safety behaviors
• Participates in cross functional safety teams
• Maintain audit readiness in laboratory

Planning - Ensure supplies and equipment are available to meet test schedules.
• Plan and execute testing schedules with no supervision; coordinates daily workflow needs of lab; Acts as Supervisor designee (all issues excluding personnel matters)
• Attend and participate production planning meetings
• Recognize lab supply needs and facilitates ordering

Technical - To perform testing activities that ensure required quality and safety standards are being met for our products.
• Perform routine chemical, physical analysis of raw materials, finished goods, products, packaging components per schedule and per standards/SOPs
• Perform non-routine testing to support validation or special projects
• Write/review/approve validation protocols and technical reports
• Execute analytical method development, validation and method/product transfer protocols
• Collect, calculate, interpret and trend test results
• Write and take ownership for SOPs related to testing programs, laboratory operations and/or equipment operation
• Participate in root cause analysis; lead and write laboratory investigations
• Investigate laboratory quality issues and recommend sound corrective actions and resolution
• Perform and review equipment calibration and maintenance; instrument advocate and subject matter expert
• Evaluate novel technology for laboratory/manufacturing application
• Identify appropriate lab instrumentation purchases; perform qualification/validation
• Conduct peer review and approval of data collected by co-workers
• Lead lab initiatives or programs and train analysts
• Perform statistical analysis
• Utilize change control systems
• Support AS&T deliverables which encompass method development and validation
• Represent the laboratory as the Subject Matter Expert in all major test disciplines and processes
• Track and report laboratory performance metrics

Interfaces - Coordinate/support other departments to ensure smooth execution of work.
• Excellent communication both verbal and written skills concerning testing and sampling scheduling with other departments and external labs/vendors
• Attend and participate in production planning meetings
• Professional and skilled interface with auditors
• Participate in the Sr. Management data review

Team - Cooperate and support coworkers to enhance overall capability of the organization.
• Lead problem solving and troubleshooting of laboratory issues and methodology
• Contributes to departmental meetings; provides technical insight and presentations
• Team Leader/Supervisor Designee
• Demonstrates overtime flexibility
• Demonstrate Alcon Values and Behaviors

• % Test/analyst
• % Test on time
• % Right first time
• % On-time training completion
• % Document Periodic Review
• Safety suggestions/input
• On time Project Completion
• Role model for leadership behaviors 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. Minimum requirements Minimum:
Bachelors of Science in Chemistry or Biochemistry
5 years applicable experience in Pharma field or related industry, experience with laboratory requirements and equipment
In-depth understanding of:
ICH Analytical Method Validation
Analytical method Transfer
USP Chapters , ,

Bachelors of Science in Chemistry or Biochemistry
7+ years applicable experience
In-depth understanding of:
• Relevant USP/EP/JP Compendial test methods ISO Cleanroom Standards (e.g. 13408, 14644)
• FDA Guidance for Industry Sterile Drug Products Produced by Aseptic Processing - Current Good manufacturing Practice
• EC Guide to Good Manufacturing Practice - Annex 1

Share this Job