Summary

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

About the Role

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.

• 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 all times
• Detail orientated and able to proof work and identify non-standard format-or wording, and errors within documents
• Drafts documents of expected quality
• Problem solve to best of one's ability.
• Support colleagues as needed
• May need to adapt to changing work shifts, both swing and/or graveyard on very short notice

• 5+ years of relevant experience in the pharmaceutical,biologics, microbiology, sterile or aseptic manufacture, -or medical device industry.
• Knowledge of cGMP and an understanding of the concepts of GLP, good clinical practices and FDA guidelines, applicable state and foreign regulations, and standards routinely used in the industry (i.e. USP ISO, Annex 1 etc.).
• Thorough knowledge of microbiological and environmental monitoring test methods.
• Micro/Environmental knowledge to facilitate investigations.
• Expert knowledge of LIMS systems.
• Able to manage stakeholders to drive projects forward for on-time delivery

• Recognized expert in execution of cGXP requirements. Superior communication and organizational skills.
• Ensure customer (internal and external) satisfaction and react to customer (internal and external) requests.
• ls an SME and seen as a competent team player.
• Is able to work independently, compliantly and is results driven.
• ls able to multitask and support junior staff members whilst conducting own work Detail Orientated.
• Able to proof work and identify non-standard format or wording, and errors within documents.
• Requires walking/ standing for extended periods (up to 6 hours) throughout the work shift.
• Requires working with commonly used disinfectants/chemicals in the industry such as 70% IPA, Spor-Klenz, and Bleach.
• Requires dexterity for fine motor tasks such as pipetting and sterile manipulations in biosafety cabinets.
• May use a computer and multiple software packages for greater than 4 hours a day.