Principal Analyst, QC

Novartis Pharmaceuticals Fort Worth , TX 76102

Posted 2 weeks ago

Job Description:

To perform product inspection and MBR review to ensure required quality standards are being met for our products.

  • Perform routine analysis of raw materials, finished goods, products, packaging components, complaints, investigations per schedule and per standards (internal/external)/SOPs as needed

  • Perform non-routine testing

  • 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

  • Enter and report 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 and evaluate lab instrumentation purchases; perform qualification/validation

  • Conduct peer review and approval of data collected by co-workers

  • Lead lab initiatives or programs

  • 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.

Key Performance Indicators:

% 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

Employment Type


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Principal Analyst, QC

Novartis Pharmaceuticals