6 jobs found

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,...

Nephron Pharmaceuticals Description:    Corporate Statement: Nephron Pharmaceuticals is a privately-owned global leader in the manufacturing of generic drug products, over-the-counter (OTC) drug products and medical devices. Nephron’s products are sterile, preservative and additive free and proudly made in the USA! We are headquartered in West Columbia, South Carolina. Our location provides the ability to develop new devices and medications including respiratory therapies, ophthalmic, and injectables, for in-house or contract manufacturing opportunities. The facility utilizes completely automated manufacturing, packaging, and distribution systems, in addition to high volume and redundant utility systems, to ensure production system availability. Nephron specializes in Blow-Fill-Seal (BFS) manufacturing, a niche technology that allows a vial of medication to be formed, filled and sealed in a continuous process, in a sterile, enclosed environment and without human...

Nephron Pharmaceuticals Description:    Job Purpose: The Metrology & Calibration Technician executes in-house calibrations, routine verifications, and diagnostics on critical manufacturing/instrument monitoring systems within a regulated cGMP drug facility. This role maintains the qualified state of production assets to ensure equipment accuracy and minimize downtime. Key responsibilities include managing scheduled calibrations for Blow-Fill-Seal (BFS) aseptic packaging systems and critical instruments ranging from environmental sensors to weight and pressure systems. All activities must strictly comply with cGMP standards, NIST traceability guidelines, and internal SOPs.       Essential Duties and Responsibilities: Instrument Calibration: Performs in-house scheduled and unscheduled calibrations on critical instrumentation, and equipment monitoring devices that affect product quality including temperature and humidity controllers, autoclaves, pressure transducers,...

Nephron Pharmaceuticals Description:    Job Purpose:  The Senior Engineering Associate provides technical and engineering support to the Manufacturing Science & Technology (MS&T) group, with primary responsibility for maintaining and controlling facility and engineering CAD drawings, supporting cleanroom construction activities, and assisting with capital and site improvement projects. This role serves as a key resource for engineering documentation, facility modifications, equipment installations, and project execution while ensuring compliance with cGMP requirements and internal quality standards. The position collaborates closely with Engineering, Validation, Quality, Manufacturing, and external contractors to support facility reliability, expansion initiatives, and operational excellence. Essential Duties and Responsibilities:    · Maintain, revise, and control facility, utility, process, and equipment CAD drawings in accordance with document control...