Quality Systems Investigator Tier I

Description

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 intervention. As an industry leader in product safety and quality, Nephron produces a variety of inhalation solutions, and has distributed over 1 billion doses of respiratory medication per year since 2009.

The company’s longstanding relationships with major drug wholesalers allow us to distribute our products to retail pharmacies, mail order pharmacies, hospitals, home care companies, and long-term care facilities. Nephron has a sales force that covers all fifty states and some international territories. Nephron exists to provide top-quality, affordable medications to everyone. Our quality first culture is built on:
Transformation
, Execution and Trust
.

The Quality Systems Investigator is responsible for evaluating, investigating, and strengthening the company’s Quality Management System to ensure compliance with pharmaceutical regulatory requirements and industry standards. This role leads and supports thorough investigations of deviations, complaints, and quality events; identifies root causes; and ensures effective corrective and preventive actions are implemented. By monitoring system performance, assessing process controls, and driving continuous improvement, the Quality Systems Investigator helps ensure the consistent manufacture of safe, effective, and high-quality products while maintaining regulatory readiness.

• Responsible to assure compliance with FDA regulations in the areas of non-conformance investigations, planned deviations, or corrective and preventive actions (CAPA’s) at Nephron Pharmaceuticals Corporation.
• Responsible for assisting with tracking and trending data related to investigations.
• Assists in developing and implementing project plans, processes, and systems to ensure timely project completion.
• Assists with additional work duties or responsibilities as evident or required.
• Performs other duties as assigned or apparent.

• Manage investigations in an effort for timely completion, maintaining electronic files, updating procedures as required, etc.
• Maintains investigation files.
• Performs initial and secondary review of compliant investigations and ensures accuracy and completeness of records.
• Work collaboratively with quality investigations team with attention to repeated occurrences of similar root causes.
• Track and report investigation trends.
• Assist Continuous Improvement Quality Manager with areas of improvement and provide insight for Quality Improvement Plans (QIPs).
• Assist with the design and development of organizational training programs, tools, and processes to build quality.
• Stay abreast of current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of procedures being performed.
• Support all departments with investigations, complaints, audit response, process improvement and training for deviations and complaints as well as the subsequent Corrective and Preventative Actions (CAPAs).
• Reports any quality related issues to Director of Quality Assurance Investigations.
• Assist in other activities (as needed) for Quality Assurance management.