Nephron Pharmaceuticals

Nephron Pharmaceuticals Description:    Job Purpose:  The BFS Maintenance Manager leads and directs all aspects of maintenance operations for Blow-Fill-Seal (BFS) equipment, ensuring maximum equipment availability, regulatory compliance, and team development in a sterile pharmaceutical manufacturing environment. This role combines hands-on technical expertise with strategic planning and personnel management to sustain and improve equipment performance across multiple BFS platforms (e.g., Rommelag 324, 460). The Manager ensures CGMP and safety standards are upheld, oversees long-range maintenance planning, and serves as a critical liaison between Engineering, QA, and Production teams. __________________________________________________________________________________________ Essential Duties and Responsibilities:  Strategic Maintenance Oversight: Ø Lead and manage daily, preventive, and predictive maintenance for BFS equipment. Ø Develop long-term strategies for...

Nephron Pharmaceuticals Description:    Job Purpose: The Change Control Continuous Improvement Manager is responsible for identifying, developing, and implementing process improvement initiatives within the Change Control and Document Revision functions. This role serves as a subject matter expert (SME) and internal lead for optimizing document lifecycle management, change control workflows, and electronic quality management system (eQMS) performance.            Essential Duties and Responsibilities: 1. Continuous Improvement — Change Control and Document Revision Lead continuous improvement efforts for change management processes, including initiation, impact assessment, approval routing, implementation, and closure.  Analyze data to identify bottlenecks, recurring delays, incomplete submissions, and compliance risks.  Establish and monitor key performance indicators (KPIs) for change control and document revision cycle time, on-time closure rates, and rejection...

Nephron Pharmaceuticals Description: Job Purpose:  Expert level of knowledge, can handle major issues with Secondary Packaging machines, can lead changeovers, capable of major troubleshooting and root cause analysis and implementing corrective and preventative actions. Able to control multiple lines efficiently. Ensures productivity goals are met or exceeded. Essential Duties and Responsibilities: · Assist the Supervisor with overseeing Secondary Packaging.  · Able to collectively cover for shift Supervisor when they are absent from the packaging area. · Perform additional work duties or responsibilities as evident or required. · Assist as needed with cleaning, adjustments and preventive maintenance on equipment. · Troubleshoot problems and assist with maintenance and repairs as needed. · Set up equipment in the correct configuration for the product scheduled / running to be processed. · Document machine startup settings and be able to write descriptive...

Nephron Pharmaceuticals Description:    Essential Duties and Responsibilities: · Perform On-the-Job (OJT), group and one-on-one trainings from department personnel. · Contact and coordinate with different departments and resources. · Evaluate and communicate training needs to upper management. · Performs all other duties as assigned or apparent. · Assist and monitor the receipt and release of railcars · Follow up with the Quality department to ensure testing · Maintain company equipment/tools utilized for resin transfers · Complete understanding of how to use the HMI for resin transfer · Check railcars for moisture levels · Assist coordinating quality sampling with the Quality Assurance department upon resin receipt · Monitoring and clearing “knuckle” of all regrind and purge · Assist with movement of wet-waste gaylords from the “knuckle” to the E80 warehouse · Monitoring of the resin regrind room, silo room, and blower house · Maintaining cleanliness of...

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 purpose of this position is to support quality control testing and research and development activities as needed by conducting laboratory testing for raw materials, in-process materials, finished product, and stability samples in accordance with approved analytical methods.     Essential Duties and Responsibilities: Conduct routine and complex laboratory testing for raw materials, in-process materials and samples, finished product samples, and stability samples in accordance with approved analytical methods.  Conduct and execute laboratory work and testing using best-practice analytical techniques and follow laboratory GDP and cGMP requirements Accurately analyze and interpret data using appropriate specifications and test methods.  Accurately peer review notebooks and verify raw data to support sample release, including data generated in electronic      software systems. Accurately enter data using...