Nephron Pharmaceuticals

Nephron Pharmaceuticals Description: The purpose of the Batch Record Review (BRR) role is to ensure that all manufacturing and packaging processes comply with regulatory standards, company policies, and quality requirements before product release. This role plays a critical part in maintaining product integrity, patient safety, and regulatory compliance by verifying that production records are complete, accurate, and meet Current Good Manufacturing Practices (cGMP) and other industry regulations (e.g., FDA, ISO).  By meticulously reviewing batch documentation, identifying deviations, and ensuring corrective actions are taken, the BRR role helps prevent product defects, recalls, and compliance issues, ultimately safeguarding public health and maintaining company credibility.     Essential Duties and Responsibilities: Oversee status of batches through disposition/release process and remove barriers, communicate escalations as appropriate. Performs final batch disposition...

Nephron Pharmaceuticals Description:   Job Purpose:  The Production Visual Inspector is responsible for performing visual inspection activities for injectable and ophthalmic pharmaceutical products in compliance with company policies and procedures, FDA regulations, and current Good Manufacturing Practices (cGMP). This role supports production and packaging operations while maintaining accurate documentation, ensuring product quality, and promoting a safe and compliant work environment. __________________________________________________________________________________________ Essential Duties and Responsibilities: · Perform 100% visual inspection of ophthalmic and parenteral drug products, including vials, syringes, ampoules, bottles, and IV bags, in accordance with cGMP requirements and approved inspection procedures · Inspect products for particulate matter, cosmetic defects, container closure integrity defects, fill level discrepancies, discoloration, cracks,...

Nephron Pharmaceuticals Description:    Job Purpose: The QC Chemistry Technician is responsible for performing routine chemical testing, sample preparation, instrument operation, and documentation to support quality control activities in accordance with approved analytical methods. This position will also provide support to day-to-day operations and functionality within the Chemistry laboratory.          Essential Duties and Responsibilities: Conduct all testing assignments directed by Chemistry Manager or Laboratory Supervisor. Conduct and execute laboratory work and routine testing using best-practice analytical techniques and follow laboratory GDP and cGMP requirements. Maintain, Verify, and Standardize laboratory equipment to ensure accuracy and precision.  Prepare solutions and standards to support analytical testing. Accurately analyze and interpret data using appropriate specifications and test methods.  Responsible for maintaining housekeeping and...

Nephron Pharmaceuticals Description:    This role is responsible for overseeing and coordinating all aspects of cleaning operations to support manufacturing priorities. It involves conducting walkthroughs, planning and scheduling cleaning activities, and ensuring timely execution in compliance with cGMP standards. The position requires strong communication with cross-functional teams to align cleaning efforts with production needs. Additional responsibilities include maintaining documentation, supporting investigations and continuous improvement initiatives, and managing personnel activities such as scheduling, assessments, and overtime approvals. The role also involves inventory oversight, including restocking supplies and working with procurement. Flexibility to assist with hands-on cleaning tasks and room status changes is essential. Overall, the position ensures a clean, compliant, and efficient environment that supports production goals.     Essential Duties and...

Nephron Pharmaceuticals Description: Commodities Technician will perform all duties as assigned or apparent. A Tech will make contact and coordinate with different departments and resources to ensure resin processes are maintained. A Tech will be able to identify all types of resins, regrind, and purge. Techs will clear and separate all waste gaylords with the correct labeling. Finally, Techs will monitor all movement of said commodities.    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...

Nephron Pharmaceuticals Description:    Job Purpose:  The purpose of the Quality Systems Scientific Specialist (Tier III) is to responsible for ensuring data integrity, compliance, and adherence to established quality standards. This role involves analyzing reports, and identifying discrepancies or inconsistencies, and escalating issues accordingly. Contribute to continuous improvement of processes and products by identifying trends all while adhering to regulatory standards and company policies.        Essential Duties and Responsibilities: • Responsible for ensuring compliance with all State and Federal regulatory bodies as it pertains to the completion of Annual Product Reviews (APR) for all Nephron Pharmaceuticals Corporation (Nephron) and Nephron 503B Outsourcing Facility (503B) drug products.  • Responsible for performing Quality Assurance reviews of Microbiology and Chemistry documents for final Quality Approval. This includes review of method validation...

Nephron Pharmaceuticals Description:    Job Purpose:  This role is to Perform research and development projects for established products and new products including but not limited to analytical test method validation/transfer/verification, reformulation, procedures, investigations, and other non-specified projects or initiatives.            Essential Duties and Responsibilities:  Plans, organizes, and manages resources on projects to assure technical quality and schedule adherence Capable of working in a GMP environment and responsible for generating GMP data.  Capable of working with different analytical techniques including but not limited to HPLC, UPLC, GC, Automatic Titrator, IR, DSC, ICP, and Mass Spectrometry.  Responsible for performing different analytical tests for R&D and QC as needed.  Responsible for executing research and development projects for established products and new product development with respect to formulation, laboratory...