High Performing QC Team Member Sought
Purpose and Scope
The Quality Control (QC) Systems Specialist supports the QC Laboratory by maintaining, troubleshooting, and repairing all analytical laboratory instruments. This includes the entire instrument lifecycle from installation to retirement.
Responsibilities
* Maintain QC systems and instrumentation in compliance with data integrity, regulatory, and industry standards.
* Manage change control processes for continued compliance of QC systems and instrumentation.
* Support QC department in troubleshooting, investigations, and deviations as Subject Matter Expert (SME).
* Oversee deviations, CAPAs, and change controls related to QC systems and instrumentation.
* Develop local Standard Operating Procedures (SOPs), work instructions, and guidelines.
* Serve as SME for regulatory and internal inspections and audits.
Requirements
* Degree in a Science or engineering-related field.
* Significant experience in analytical instrument maintenance, with CSV experience an advantage.
* Excellent understanding of data integrity compliance requirements.
* Able to drive complex tasks to completion.
* Strong organizational, problem-solving, and continuous improvement skills.
* Ability to prioritize activities based on maintenance schedules and business needs.
* Flexible to adapt to changing business needs.
* Familiarity with change management requirements of validated systems and software.
* Exceptional communication skills both verbally and in writing.
* Capable of handling multiple projects and meeting critical deadlines.
* Able to work independently and manage time effectively.
* Team player with excellent coordination and goal-oriented skills.
* High level of self-motivation, enthusiasm, and drive.