• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description:

Our client is looking for someone to assist with LabX methods for QC lab data management activities. The client just installed Lab X and recently went live; they need someone to go back into LabX to modify existing methods to get deployed out to 7X and pH meter. As it pertains to LabX, this person will be reviewing methods, troubleshooting methods, work with end users on troubleshooting and testing. The methods are all customized and there will be vendor support, however it’s important that the selected resource can speak the language to vendors when they run into issues and comprehend what users are asking in order to transfer it into method design components and method validations up & running. The next phase will be user-intensive with meter testing and working with vendors to resolve bugs. There are internal resources to get them through the GMP system, but they need someone to help them also from a documentation-standpoint. 

Responsibilities:

• Testing, validating, and implementing new methods, ensuring they meet GMP standards, and supporting the transition from development to production environments.
• Work closely with internal teams and vendors to ensure smooth transitions from development to production, and roll out validated methods to multiple QC labs.
• Support change control processes, ensuring proper documentation for regulatory compliance, and assist with the execution of change controls for deployment.
• Facilitate the transition of methods from development to production, including testing, validation, and deployment.

Requirements: 

• Experience with LabX or similar lab management systems.
• Strong method customization and troubleshooting skills within a laboratory setting.
• Understanding of server-based systems, ideally SQL-based servers, and LabX infrastructure.
• Knowledge of GMP and 21 CFR Part 11 regulations.
• Strong communication skills to collaborate with vendors and internal teams.

Nice to Have (Bonus Skills):

• Knowledge of server configuration and understanding how LabX integrates with server systems.

Physical Demand:

While performing the duties of this job, the employee is regularly required to stand, walk, and sit for extended periods of time. Occasionally the employee may be required to lift or move at least 20 pounds. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.