Senior QC Instrument Specialist - (28664)

 

At Guerbet, we build lasting relationships so that we enable people to live better.  

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, as well as digital and AI solutions for diagnostic and interventional imaging. As a pioneer in the field of contrast products for the last 95 years, we continuously innovate.   

  

Achieve, Cooperate, Care, and Innovate are the values ​​that we share and practice.  

  

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube. 

 

WHAT WE'RE LOOKING FOR:

As a Senior QC Instrument Specialist, you will be responsible for ensuring the reliability and compliance of our laboratory equipment, managing equipment-related change controls, and contributing to the validation of instruments used in quality control processes. You will play a crucial role in maintaining the highest standards of quality in our pharmaceutical products.

 

YOUR ROLE:

1. Equipment PM (Preventive Maintenance):

   • Perform routine and preventive maintenance on laboratory equipment to ensure optimal performance and compliance with industry standards.

   • Develop and maintain a schedule for equipment maintenance, ensuring minimal impact on laboratory operations.

2. Equipment Validation:

   • Author and execute equipment validation protocols, including Installation, Operational, and Performance Qualification (IOPQ) in accordance with regulatory requirements.

   • Generate validation reports, documenting results and ensuring equipment meets established acceptance criteria.

3. Change Control Management:

   • Manage all equipment-related change controls, including assessing the impact of changes on equipment performance and regulatory compliance.

   • Collaborate with cross-functional teams to implement changes, ensuring minimal disruption to QC processes.

4. Calibration and Troubleshooting:

   • Calibrate instruments as needed to maintain accuracy and precision.

   • Troubleshoot and diagnose equipment issues, coordinating repairs and maintenance with vendors or internal resources.

5. Documentation and Compliance:

   • Maintain accurate records of equipment maintenance, calibration, and validation activities.

   • Ensure compliance with cGMP (current Good Manufacturing Practices) and other relevant regulatory requirements.

6. Training and Support:

   • Provide training and guidance to laboratory personnel on proper equipment operation and maintenance.

   • Stay updated on industry trends, best practices, and emerging technologies in laboratory instrumentation.

7. Non-essential functions

   • Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment.  Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk.  Report all safety and/or environmental incidents to management immediately.

   • Other duties as assigned with or without accommodation.

 

YOUR BACKGROUND:

Education required/preferred:

• Bachelors Degree in Chemistry (preferred) or other science with General, Organic, and Analytical chemistry coursework

Experience Preferred

• Minimum of 5 years of QC Laboratory experience with heavy emphasis on qualifying and/or maintaining testing instrumentation in an FDA regulated environment (pharmaceutical mfg preferred)
• Strong knowledge of cGMP and regulatory requirements related to QC instrumentation
• Experience in authoring and executing equipment validation protocols (IOPQ)
• Proficiency in troubleshooting and performing routine maintenance on laboratory instruments.

Skills/Qualifications

• Ability to establish priorities and demonstrate leadership
• Ability to perform multiple tasks simultaneously with accuracy and precision. 
• Self-motivated, energetic, enthusiastic, and team oriented
• Excellent organizational skills with the ability to manage multiple tasks and priorities effectively.
• Strong communication and teamwork skills, with the ability to collaborate across departments
• Effective com