Senior Scientist, QC Microbiology

Job Description Summary

Manages Quality aspects and projects within area of responsibility. -Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.  

 

Job Description

Hours: Monday - Friday 8-4:30pm

Location: This opportunity is located in Morris Plains, NJ and will not have the ability to be located remotely.

Job Purpose:

Independently perform QC Microbiology testing, generate and analyze EM trend reports and other activities supporting the QC department

 

Major Accountabilities:

• Serve as delegate for Manager for Microbiology.
• Serve as Quality Control representative on cross-functional teams.
• Perform Microbiology testing such as a growth promotion, gram stain, water sampling and testing in support of clinical and commercial manufacturing strategies.
• Document results within electronic and paper-based systems accordingly.
• Execute and follow SOPs and quality policies.
• Generate and analyze trend reports (monthly, quarterly) to determine appropriate course of action.
• Review reports that are generated and take required action based on the data.
• Review/approve data generated by other team members. Adhere to site wide through put times (TpT).
• Reviews laboratory logbooks and laboratory cleaning monthly.
• Verify the accuracy of data generated.
• Review QC documents to ensure completeness, accuracy, consistency and clarity.
• Author and revise documents and quality policies as required.
• Ensure cleanliness of laboratory working areas.
• Ensure all assigned training is completed within-required time frame.
• Complete Train the Trainer course and train others on specified tasks.
• Oversee and maintain the gowning qualification program and ensure program is kept current.
• Lead and implement process improvements.
• Initiate and lead special projects and facilitate any issues that arise.
• Execute method qualification/optimization as needed.
• Independently lead OO S/OOE/OOT and deviation investigations of high complexity.
• Drive complex investigations to understand root cause.
• Implement effective CAPAs in a timely manner.
• Perform required impact assessments and quality risk assessments.
• Expert in quality systems such as 1QE,  ESOPS D2, Condor, LIMS, and Subway.
• Knowledge of MODA- EM system
• Support SS and Lean projects.
• Interface with regulatory agencies during audits.
• Perform other job duties as assigned.

 

Key Performance Indicators:

• Flawlessly delivers quality results on time to all customers, internal and external.
• Recognized specialist in any particular field of laboratory matters and is capable to confidently communicate' technical information to regulatory inspectors.
• Complies with SOPs and GxP’s in a consistent and compliant manner.
• Escalate issues and potential solutions to laboratory management in a timely manner.
• Ensures assigned assays can be executed at