Nephron Pharmaceuticals

Nephron Pharmaceuticals Description:    Job Purpose:  The Secondary Packaging Lead is responsible for overseeing daily operations of secondary packaging lines, ensuring safe, efficient, and compliant production. This role provides hands on leadership to operators, technicians, supports troubleshooting efforts, and drives continuous improvement initiatives to maximize equipment uptime and overall line performance.         Essential Duties and Responsibilities: Follow all SOPs set forth by Nephron Pharmaceuticals. Lead and coordinate day to day of secondary packaging operations. Serve as the first point of contact for operational issues, escalating when necessary. Support troubleshooting of mechanical, electrical and automation-related faults to minimize downtime. Ensure adherence to cGMP, safety, and quality standards. Monitor line performance and drive improvements in OEE (Overall Equipment Effectiveness) Verify proper line setup and changeovers are completed...

Nephron Pharmaceuticals Description:    Job Purpose:  Oversees the production machine operations while assisting with additional duties and responsibilities as needed or required, and performs other tasks as assigned or apparent.           Essential Duties and Responsibilities: • Communication to/from peers via production log book, and face-to-face communication with on coming/off-going supervisor.  • Ensure product lines are running within time guidelines for changeovers, with correct lot# and expiration date, formulations, clean in place and product transfer.  • Verify all Batch Records and Lot Records are complete to meet GMP requirements to include all required signatures and or initials.  • Ensure training of new hires and any personnel involved in cross training.  • Monitor employee attendance/tardiness and provide guidance and discipline when appropriate, monitor timecards, vacations, personal time, etc., to ensure production lines are staffed in order to...

Nephron Pharmaceuticals Description:   Job Purpose:  Microbiology Quality Investigators ensure compliance with FDA regulations in the areas of microbiology-related investigations. Microbiology Quality Investigators are responsible for ensuring the Microbiology department’s adherence to FDA regulations. This involves completion of non-conformance investigations, the drafting of pertinent memorandums, managing deviations, and implementing robust corrective and preventive actions (CAPAs). A key aspect of the role is effective inter-departmental collaboration to facilitate the timely completion of all projects. Furthermore, investigators must skillfully manage their individual workload and adapt to shifting priorities to meet departmental and company demands.            Essential Duties and Responsibilities: Effectively completes microbiology excursion reports and associated documentation per procedure within specified      timelines.  Executes timely completion of CAPAs,...