What are the responsibilities and job description for the QC Equipment Validation Specialist position at Katalyst Healthcares & Life Sciences?
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.
- Author 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.
- Act 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.
- Apply 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.
- Act 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.
- Ability to multitask, prioritize and coordinate work to meet customer's needs.
- Demonstrate problem solving and investigative skills.
- Ability to make decisions based on knowledge, experience, best practices and requirements.
- Ability 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.
- Ability 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.
- Ability to work cross-functionally.
- Excellent written and oral communication skills and ability to collaborate and interact with management, scientists, engineering and IT personnel.
- Ability to work 8-hour days Monday through Friday.
- Ability to work overtime as required.
- Limited travel may be required during project phase.
