Nephron Pharmaceuticals

Nephron Pharmaceuticals Description:   Job Purpose:  Secondary Packaging’s main objective is to place primary packaged products into outer packaging that provides additional protection for distribution and retail. The secondary packaging process ensures the safe, compliant, and efficient transport of the pharmaceutical products.          Essential Duties and Responsibilities: Operate the Secondary Packaging equipment and determine trends (i.e. vials per minute and pallets packaged per shift). Responsible for changeovers and end of lot procedures.  Responsible for documenting in the MBR.  Responsible for operating and repairing minor problems with Secondary Packaging equipment.  Responsible for clearing machine jams and minor adjustments.  Perform line clearances, machine challenges, exhibits, and startup checklist. Perform cleaning, vacuuming, and other housekeeping duties to maintain a high level of cleanliness of the Secondary Packaging lines. Be familiar...

Nephron Pharmaceuticals Description: Job Purpose:   Utilities Maintenance Technicians are to ensure the reliable, efficient, and compliant operations of critical utility systems that support manufacturing. Maintain GMP and non-GMP equipment by preforming preventive maintenance, and repairs on equipment such as: HVAC and cleanroom environmental controls. Purified Water (PW), Water for Injection (WFI), and Pure Steam systems. Boilers, chillers, air compressors, and refrigeration units. Process gases (nitrogen, compressed air) and waste systems. Essential Duties and Responsibilities:  Responsible for higher level troubleshooting, repairing, maintaining and directing the installation of all plant utility equipment. Assists with additional work duties or responsibilities as evident or required. Performs other duties as assigned or apparent. Maintain all plant utilities equipment including HVAC, boilers, steam generators, multi-effect still, air compressors,...

Nephron Pharmaceuticals Description:   Job Purpose: Performs human resources administrative duties in the Human Resources Department to include health and dental benefits, payroll, payroll deductions, on-boarding, FMLA designation, retirement, 401k, HSA administration, and Annual Open Enrollment. Assists with the daily administration and implementation of core and optional plans for all active employees, and COBRA participants. Ensures that all employee enrollments and/or changes follow each Plan Document, Nephron policies, Internal Revenue Service 125 plan regulations, and Federal and State laws.    ____ Essential Duties and Responsibilities: Ø Develops, coordinates, and conducts the new hire on-boarding process. Completes all employment related forms and ensures compliance. Ø Interacts with Payroll to facilitate the bi-weekly payroll process also serves as liaison between payroll and departments as necessary.   Ø Handles all payroll transactions to include but not...

Nephron Pharmaceuticals Description:    Job Purpose:  The Microbiology Environmental Monitoring (EM) Technician I is an entry level position that performs monitoring of air quality, environmental, and personnel throughout the facility. EM Technician I collects samples of water for injection (WFI) and performs enumeration. EM Technician I assists EM Leads, Supervisors, and Management with additional responsibilities as delegated. EM Technician I must uphold cGMP and Nephron’s core beliefs.            Essential Duties and Responsibilities: Performs daily activities to monitor environment, air quality, and personnel samples in production area.  Performs enumeration of environmental monitoring samples. Completes sampling on a daily basis for the facilities’ WFI system program.  Performs personnel and environmental monitoring per procedure for all production areas.  Maintains strong aseptic technique when operating in cleanroom environments. Manages time in a way that...

Nephron Pharmaceuticals Description: Position Summary: Performs Weight Check and Quality Attributes Inspection of the product through the filling and packaging process in compliance with company policies/procedures, FDA and cGMP regulations. Ensures the accuracy and completeness of batch records. Performs other duties as assigned or apparent. Primary Accountabilities: Successfully complete required Quality Assurance Training as outlined per procedure.  Successfully complete DEA certification. Review production batch records for accuracy and completeness. Monitor and perform start up, in-process and finished product inspections including weight checks and attribute inspections during production. Maintain quality assurance documentation. Promote teamwork both within the QA area and other departments. Keep line and work station clean and orderly. Inspect and release machines and processing rooms for production. Support validation and manufacturing studies...

Nephron Pharmaceuticals Description: Position Summary: Performs Weight Check and Quality Attributes Inspection of the product through the filling and packaging process in compliance with company policies/procedures, FDA and cGMP regulations. Ensures the accuracy and completeness of batch records. Performs other duties as assigned or apparent. Primary Accountabilities: Successfully complete required Quality Assurance Training as outlined per procedure.  Successfully complete DEA certification. Review production batch records for accuracy and completeness. Monitor and perform start up, in-process and finished product inspections including weight checks and attribute inspections during production. Maintain quality assurance documentation. Promote teamwork both within the QA area and other departments. Keep line and work station clean and orderly. Inspect and release machines and processing rooms for production. Support validation and manufacturing studies...

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:    Essential Duties and Responsibilities: Coordinates      daily activities to monitor environment, air quality, and personnel  samples in production area and complete daily review of aseptic monitoring data entry and/or form completion. Ability  to monitoring in all ISO classified production areas.  Coordinates sampling program for facility water for injection (WFI) system. Assists with training of newly hired EM Technicians; also ensures the continuous  training of all of EM Techs in all cleanroom production areas, and with all new equipment and machines (including, but not limited to, Continuous Particle Measuring System).  Executes data entry and/or form completion and verification.  Performs additional laboratory tasks and assists in EM-related projects as needed.  Ensures EM Technicians are utilizing MODA per procedure, and assist Microbiology Management in providing trend data and reports for analysis. Develops and...

Nephron Pharmaceuticals Description:    Job Purpose:  The Production Change Control Manager is responsible for overseeing and managing change control activities related to manufacturing operations , including production processes, equipment, facilities, materials, and associated documentation. This role ensures compliance with FDA regulations, cGMPs, and internal quality systems by evaluating the impact of proposed changes, implementing appropriate controls, and maintaining product quality, safety, and regulatory compliance. The Production Change Control Manager serves as a subject matter expert (SME) for change control within manufacturing and provides guidance to cross-functional teams to ensure changes are properly assessed, documented, approved, and implemented          Essential Duties and Responsibilities: Manage and oversee production-related change control activities in accordance with FDA regulations, cGMPs, and      company quality policies. Facilitate...

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...

Nephron Pharmaceuticals Description:    Job Purpose:  Secondary Packaging’s main objective is to place primary packaged products into outer packaging that provides additional protection for distribution and retail. The secondary packaging process ensures the safe, compliant, and efficient transport of the pharmaceutical products.           Essential Duties and Responsibilities: · Operate the Secondary Packaging equipment and determine trends (i.e. vials per minute and pallets packaged per shift). · Responsible for changeovers and end of lot procedures.  · Responsible for documenting in the MBR.  · Responsible for operating and repairing minor problems with Secondary Packaging equipment.  · Responsible for clearing machine jams and minor adjustments.  · Perform line clearances, machine challenges, exhibits, and startup checklist. · Perform cleaning, vacuuming, and other housekeeping duties to maintain a high level of cleanliness of the Secondary Packaging lines....

Nephron Pharmaceuticals Description:    Job Purpose: Secondary Packaging Maintenance Technicians are responsible for repairing, maintaining, troubleshooting issues on the Packaging machines and documenting all work while adhering to all safety procedures.  Essential Duties and Responsibilities: Perform preventative maintenance on automated packaging lines Ensuring procedures are followed when performing maintenance. Perform electrical and mechanical maintenance on fully automated equipment.  Ability to troubleshoot a variety of equipment and problem solving skills  Use time management wisely and effectively  Maintain and /or repair of conveyors, gear boxes, motors, inkjet printers, sensors and robotics.  Daily production line walkthroughs to ensure problems are caught before production demands are jeopardized.  Complete On the Job Training in a timely manner  Ability to follow cGMP’s and good documentation practices.   Communicate with a daily pass down to...

Nephron Pharmaceuticals Description:    Job Purpose:  Secondary Packaging’s main objective is to place primary packaged products into outer packaging that provides additional protection for distribution and retail. The secondary packaging process ensures the safe, compliant, and efficient transport of the pharmaceutical products.         Essential Duties and Responsibilities: Monitor the operation of Secondary Packaging equipment to determine trends (i.e. vials per minute and pallets packaged      per shift. Responsible for overseeing changeovers and end of lot procedures. Responsible for reconciliation in the MBR. Responsible for training new personnel on your shift.  Responsible for starting, stopping and repairing minor problems with Secondary Packaging equipment.  Initiate and manage any document, equipment, or process change related to non-conformance investigations as      corrective/preventive action. Coordinate training sessions on new documents or...

Nephron Pharmaceuticals Description:    Job Summary The BFS Line Technician I plays’ a vital role in ensuring the efficient and compliant operation of Blow-Fill-Seal machinery used in the production of sterile pharmaceutical products. This position is responsible for operating, monitoring, and maintaining BFS downstream equipment, ensuring product quality, and adhering to all Current Good Manufacturing Practices (CGMP), safety regulations, and company protocols. Key Responsibilities Equipment Operation Set up and operate BFS      downstream machinery according to established SOPs and Batch Records. Monitor machine performance      and production output to ensure efficiency and compliance. Perform routine adjustments      and troubleshoot minor issues to maintain continuous operation. Reset equipment alarms and      ensure all materials are properly staged for production. Quality Assurance & Documentation Accurately complete Batch      Records, logbooks,...

Nephron Pharmaceuticals Description: Job Purpose:  Provide real-time QA oversight across BFS and aseptic manufacturing to ensure compliant, accurate, and efficient execution of GMP production activities. Ensure full adherence to FDA, cGMP, and internal Quality System requirements through on-floor presence, documentation oversight, and cross functional coordination. Lead, develop, and support the Quality Operations team, promoting a strong culture of compliance, ownership, and right-first-time performance. Drive operational and quality excellence through proactive issue identification, timely decision-making, and effective cross functional partnerships. Support continuous improvement initiatives to strengthen documentation practices, reduce deviations, and enhance audit readiness. Oversee and support Visual Inspection operations   Essential Duties and Responsibilities: Provide daily oversight of BFS and aseptic operations, including observation of critical...