Novartis QC Microbiology Manager Vacancy – ApplyNovartis QC Microbiology Manager Vacancy – ApplyNovartis QC Microbiology Manager Vacancy – Apply
Novartis QC Microbiology Manager Novartis Microbiology Job. Novartis invites postgraduate and undergraduate Microbiology candidates for the post of research scientist in the field of respiratory science. BS Microbiology job opening. MS JOB opening at Novartis. Check out all the details on the same below:
Job Title: Manager, QC Microbiology (Multiple Positions)
Location: Morris Plains
Job Description:Â
The Quality Control Microbiology Manager will coordinate and lead all activities to ensure the timely testing and release of all results under the scope of the QC Microbiology department in support of CAR-T manufacturing operations. Governance responsibilities include; Environmental Monitoring, Growth Promotion, EM plate reads, Microbial Identifications, Water Testing, Bioburden, Aseptic Process Validation, Gown Qualification, Aseptic Operator Qualification, and another associated microbial testing. Lead a group of lab associates and represent QC leadership. Deliver quality products and services on time to all customers, internal and external. Provide employees with training opportunities and resources to meet or exceed customer requirements. Monitor processes and products to identify opportunities for continuous improvement. Serve as the subject matter expert on specific areas and techniques. Set up organizational structures to improve efficiency and throughput. Engage in projects to assure GMP beyond compliance.
Minimum requirements
Novartis QC Microbiology job
What you’ll bring to the role:
• Bachelor’s degree required, preferably in Microbiology or related science.
• Minimum of 3 years’ previous leadership/management experience required
• Thorough knowledge of cGxP expectations
• Novartis QC Microbiology Knowledge of ICH, Eur. Ph., USP and FDA and JP guidelines
• SME level knowledge of Microbiology and aseptic manufacturing
• Experienced in supporting/writing OOS/OOE/OOT and/or deviation investigations
• Experience in supporting internal and/or external laboratory audits
• Advanced experience in the use of computer-based systems and applications associated with QC Microbiology testing analysis and reporting
• Ability to work different shifts, weekends and overtime will be required – your shift will be fixed according to business need
• Position will be filled at level commensurate with experience.
Desirable Requirements
• Advanced degree preferred
Your responsibilities will include but not limited to:
• Responsible for management and scheduling of Microbiology laboratory personnel within the department ensuring site and department objectives are met
• Novartis QC Microbiology Ensure employees are properly trained and qualified to perform assigned tasks, provide performance evaluations and support career development of direct reports
• Provide feedback (formal and informal) to team members on a routine basis
• Primary point of contact for communication to Senior Management and cross-departmental communication during shifts
• Review and approve EM data, release test data and any other Microbiology lab da-ta/logbooks as required
• Trend and manage department/facility key performance indicators (KPI) as appropriate
• Assist in investigations (deviations/OOS/OOE) and effective CAPA implementation and ensure timely closure
• Perform level 1 OOS investigation interviews and write associated test plans as necessary
• Lead and manages the application, maintenance, validation and review of quality standards, SOP, documents and methods for processing and/or testing
• Novartis QC Microbiology Ensure that personnel are following appropriate SOPs/protocols/Work Procedures/Forms and being followed when tasks are being performed
• Ensure all samples and reagents have been prepared, tested or inspected according to specifications and current testing
• Ensure that QC Microbiology laboratories are always in an audit-ready state and maintain GMP and GLP systems and environment
• Ensure that all safety requirements are met for the laboratory areas
• Knowledge and familiarity with LIMS systems (Labware), Trackwise, and ESOPs
• Drive 5S and Lean projects, and lead the optimization of procedures to improve efficiency whenever possible
• Plan, develop and work on special project work as needed
• Participate in cross-functional meetings as needed
