QC Equipment Validation Specialist - Katalyst Healthcares and Life Sciences : Job Details

QC Equipment Validation Specialist

Katalyst Healthcares and Life Sciences

Job Location : Concord,NC, USA

Posted on : 2025-08-05T07:46:48Z

Job Description :
Responsibilities:
  • This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up.
  • The Quality Control Laboratory assures patients worldwide receive safe and efficacious drug and drug/device combination products through effective execution of product testing.
  • uthor equipment qualification/validation protocols and strategies for the QC Laboratories.
  • Provide support for equipment relocation and qualification associated with Concord Lab master plan.
  • Participate/lead in data integrity controls and improvement initiatives.
  • Technical review and execution of qualification/validation protocols.
  • Recommend and specify equipment purchases based on user requirements.
  • Communicate with other functions and external vendors regarding qualification issues and key operational objectives.
  • ct as liaison between the maintenance team and lab personnel to schedule preventative and corrective maintenance of equipment.
  • Responsible for design and execution of laboratory CSV initiatives, System Administrator duties, system upgrades, and data integrity.
  • pply knowledge of quality principles, GMPs, federal regulations, corporate standards and practices and local procedures in the development of qualification/validation protocols and equipment lifecycle management.
  • Interact effectively with customers, support groups and development.
  • Network with other areas to understand best practices, share knowledge, participate in global meetings and web seminars, and to ensure customer needs are met.
  • Influence improvements and streamline quality systems relating to equipment.
  • Serve as equipment expert and technical resource in the review of technical documents.
  • ct as subject matter experts and originator of change controls.
  • Investigate TrackWise CAPA records.
  • Interact with Global Quality Lab Equipment function to set global corporate policy regarding equipment.
  • bility to multitask, prioritize and coordinate work to meet customer's needs.
  • Demonstrate problem solving and investigative skills.
Requirements:
  • bility to make decisions based on knowledge, experience, best practices and requirements.
  • bility to work independently and accurately with minimal supervision.
  • Bachelor's degree in a science or engineering related field (Chemistry, Biology, Mechanical Engineering, Biomedical Engineering, etc).
  • 5 or more years of laboratory experience with emphasis on laboratory equipment.
  • Experience supporting laboratory equipment in a GMP environment.
  • bility to manage and contribute to multiple concurrent project activities and adapt to changes in priorities.
  • Understanding of compliance requirements and regulatory expectations for lab systems.
  • Previous experience with managing data integrity regulations and controls.
  • Working knowledge of CMMS, Kneat, Empower, TrackWise, LabVantage LIMS, Veeva.
  • bility to work cross-functionally.
  • Excellent written and oral communication skills and ability to collaborate and interact with management, scientists, engineering and IT personnel.
  • bility to work 8-hour days - Monday through Friday.
  • bility to work overtime as required.
  • Limited travel may be required during project phase.
Apply Now!
Similar Jobs ( 0)
-- View More Similar Jobs --