Principal QC Analyst (19-00194) – TX – Fort Worth

Duties:
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.
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 Client 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
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

Skills:
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 <1224>, <1225>,<1226>
Preferred: 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

Education:
Bachelors of Science Preferred: Bachelors of Science in Chemistry or Biochemistry
 
Source: Job Diva – Job Listing

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