Nephron-Pharmaceuticals
QO Visual Inspector Tier I (M-F 10pm-6:30am)
Description Job Purpose: Perform Quality Attributes and Visual Inspection of drug product through the packaging process including Visual Inspection in compliance with company policies / procedures, FDA and cGMP regulations. Ensures the accuracy and completeness of manual and electronic batch records
Manufacturing Process Investigator
Description Job Purpose: A Manufacturing Process Investigator is a professional who conducts thorough investigations into issues that arise within a manufacturing environment, focusing on deviations, non-conformances, and other quality concerns. They aim to identify the root cause of these issues, i
Security Officer
Description Job Purpose: The Security Officer is responsible for safeguarding controlled substance storage areas, facility property, and designated access pathways through active guarding, patrolling, and monitoring activities. This role supports the prevention of theft, diversion, violence, unautho
Secondary Packaging Maintenance Technician I
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
Secondary Packaging Manager
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 product
Batch Record Reviewer
Description Job Purpose: 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
Senior Quality Specialist – Contract Manufacturing
Description Job Purpose: The Senior Quality Specialist – Contract Manufacturing is responsible for providing quality oversight, project coordination, and regulatory compliance support for contract manufacturing organization (CMO) activities. This position serves as a primary liaison between internal
Senior Quality Specialist – Contract Manufacturing
Regulatory Affairs Director
Description Job Purpose: The Director, Regulatory Affairs and Device Quality Systems provides strategic and operational leadership for all regulatory and device-quality activities across Nephron’s manufacturing divisions and affiliated entities. The role ensures end-to-end regulatory compliance, pos
Gown Certification Coordinator
Description Job Purpose: The Microbiology Gowning Certification Coordinator is an expert on gown certification training as well as monitoring performed as an EM Technician I and EM Technician II. Microbiology Gowning Certification Coordinator will lead all gown certification training and plating, as
Quality Operations Materials Management Specialist
Description Job Purpose: The Quality Operations Materials Management Specialist is responsible for performing the full range of inspection, sampling, and disposition activities for specified raw materials, production components, and resin. Specialists work with other departments to ensure receipt, s
Quality Operations Secondary Packaging & Warehouse Assistant Manager
Description Job Purpose: The Assistant Manager, Quality Operations, Secondary Packaging & Warehouse provides Quality oversight and leadership for secondary packaging, finished goods warehousing, shipping, returns, and related Quality Operations activities. This position ensures compliance with curre
Quality Operations Secondary Packaging & Warehouse Assistant Manager
Quality Operations Primary Packaging Tier I (Nights 6:00pm - 6:30am)
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 as
Instrumentation Specialist
Description Job Purpose: • Oversees all aspects of the laboratory instrumentation in the chemistry laboratory • Assists with additional work duties or responsibilities as evident or required. • Performs other duties as assigned or apparent. • Relies on experience and judgment to plan and accomplish
Operations Technician I - Secondary Packaging (Multiple Shifts Avail.)
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 product
Operations Technician I - Secondary Packaging (Multiple Shifts Avail.)
Quality Operations Primary Packaging Supervisor (Shift 3 6pm-6:30am)
Description Job Purpose: · Be accountable and responsible for Compliance on shift. · Performs Weight Check and Quality Attributes Inspection of the product through the filling and/or packaging process in compliance with company policies / procedures, FDA and cGMP regulations. · Ensures the accuracy
Quality Operations Primary Packaging Supervisor (Shift 3 6pm-6:30am)
Training Coordinator
Description Job Purpose: Under the leadership of the Director of Training and Development, the Training and Development Coordinator collaborates with operational leaders to design, implement, and deliver comprehensive training programs that ensure compliance with cGMP regulations, enhance employee p
DEA Compliance Manager
Description Job Purpose: The DEA Compliance Manager is responsible for ensuring the organization complies with the regulations set forth by the Drug Enforcement Administration (DEA). This role serves as the organization’s subject matter expert for controlled substances and as a power of attorney for
Primary Packaging Operations Associate
Description Job Purpose: Serves as the Operations Associate for Manufacturing Operations and provides direct support to the Executive Vice President of Manufacturing Operations, Vice President of Manufacturing BFS and their direct reports. Oversees day-to-day functions with the development and imple
Sterile Room Supervisor (Shift 1 6am-6:30pm)
Description Job Purpose: 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.
Analytical Chemist I
Description Job Purpose: The purpose of this position is to support quality control testing and research and development activities as needed by conducting routine laboratory testing for raw materials, in-process materials, finished product, and stability samples in accordance with approved analytic