Valeant Pharmaceuticals Sr. NC/CAPA Quality Specialist in Rochester, New York

Overview:

Bausch + Lomb , a Valeant Pharmaceuticals International, Inc. company, is a leading global eye health organization that is solely focused on protecting, enhancing, and restoring people’s eyesight. Our core businesses include ophthalmic pharmaceuticals, contact lenses and lens care products, and ophthalmic surgical devices and instruments. We globally develop, manufacture and market one of the most comprehensive product portfolios in our industry, which are available in more than 100 countries.

Specialties

Eye health, ophthalmic pharmaceuticals, ophthalmic surgical products, contact lens and lens care products

The Senior Quality Specialist will support Corrective and Preventive Actions

(CAPA) and Non-conformances (NC) systems and related quality activities. The position also supports new quality system/methodol ogies implementation, training,and problem solving.

This position will also work directly with Regional Quality,Regional Functions and Departments, and External Suppliers to provide sustaining quality and compliance

leadership in the specific areas related CAPA and Non-conformance, training,and problem solving. In addition the positionIs responsible for reporting key quality metrics to drive quality and efficiency.

The position also supports compliance remediation projects.

Responsibilities:

  • Facilitate implementation of CAPA and NC systems.

  • Mentor, coach,and guide users of the CAPA and NC systems,Including;problem definition,root causeInvestigation,CAPA action determination,CAPA effectiveness.

  • Monitor quality of CAPA and NC records and work with owners to address issues.

  • Contribute to the continuous improvement of the CAPA and NC systems based on use patterns and user feedback.

  • Develop, Implement and manage CAPA review board.

  • Develop and report quality metrics on CAPA and NC performance.

  • Assist functional areas with systematic problem-solving methodologies when resolving quality issues.

Qualifications:

  • Bachelor of Science degree in anengineeringdiscipline (Mechanical,Biomedlcs, materials,lndustrlal,etc) or related technical field (microbiology,chemistry, etc) is required.

  • ASQ Certification preferred but not required (such as CQA, CQE,CMQ/QE).

  • Demonstrated working experience and expertise In CAPA and non-conformance systems.

  • Excellent communication skills (verbal and written).ExperienceIn problem solving and root cause illnalysis.

  • Ability to successfully Influence others within project teams regarding quality or compliance concerns.

  • Excellent organizations and presentation skills.

  • Minimum 10 years with CAPA and NC in the Medical Device or Pharmaceutical

  • Industryls required), including;root cause analysis and statistical techniques such as Cause and Effect Analysis,s Whys,Six Sigma processes.

  • Ability to motivate and mentor users to increase proficiency with CAPA and NC management.

  • Expertise in implementing and maintaining quality systems.

Job ID 7895

Location US - NY - Rochester

Category R&D

Pos. Type Full Time