Valeant Pharmaceuticals

Quality Specialist

US-FL-Tampa
Job ID
9105
Pos. Category
Operations
Pos. Type
Full Time

Overview

Lead process excellence and lab/stability related non-conformances within QC Chemistry/Stability. Identify projects for continuous improvement within the QC Chemistry and Stability departments and drive projects to completion. Oversees the training program for all of the technicians within QC Chemistry. Ensures Chemistry department is in compliance with all cGMP compliance criteria including compendial updates to the raw material specifications. Monitor/report monthly departmental metrics and determine areas for improvement and implement change. Take on additional duties as required in a team environment. Change Management Expert and implements changes that will improve the department's performance/efficiency/compliance. Must have a working knowledge of MS Word, MS Excel, PowerPoint. Must work well independently and in a team environment.

Responsibilities

  1. Point-person for projects related to and/or involving QC Chemistry.
  2. Review and disposition applicable test data, if needed.
  3. Create and revise analytical laboratory SOP's, raw material and chemical specifications, and other documentation.
  4. Perform and facilitate lab investigations, NCR investigations, CAPA creation and implementation. Computer software programs: Waters         Empower, GLIMS, CatsWeb, ComplianceWire, and additional computer support programs as required.
  5. Service as technical expert on laboratory procedures and methodology.
  6. Support site Quality Plan and Goals as defined annually.
  7. New project support for: Research and Developmental, contract manufacturing and regulatory filings.

8.         Support Manufacturing Excellence initiatives. All other duties as assigned

Qualifications

  • Minimum Bachelor Chemistry or related science.
  • Skilled in conducting laboratory analysis using wide array of analytical tools.

•           Working knowledge of Waters Empower 3 HPLC, Hewlett-Packard           GC, lnnovaSystems nasal automation technology.

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