Corporate Statement

Nephron Pharmaceuticals Corporation 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 located in West Columbia, South Carolina. Our location provides the ability to develop new devices and medications including respiratory therapies, ophthalmics, 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. Nephron is currently working on research and development projects that include over 50 new products.  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 Puerto Rico, with additional sales channels throughout South America, the Middle East, and Europe. Nephron exists to provide top-quality, affordable medications to everyone.

Position Summary:

· Responsible to assure compliance with FDA regulations in the areas of non-conformance investigations, planned deviations, or corrective and preventive actions (CAPAs) at Nephron Pharmaceuticals Corporation.

· Collaborates with a cross functional team to drive a culture that prevents future deviations through a robust and proactive investigation process. 

· Lead the development, implementation, and improvement of the Investigation QMS including policies, processes, and procedures to satisfy a quality compliance culture.

· Assists with additional work duties or responsibilities as evident or required.

· Performs other duties as assigned or apparent.

Primary Accountabilities:

NOTE: The primary accountabilities below are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed below. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager.

· Manage investigations in an effort for timely completion, maintaining electronic files, updating procedures as required, etc.

· Performs reviews and approvals of investigations and ensures accuracy and completeness of records.

· Partner with the Quality Management to provide leadership and guidance on investigation governance across all business functions.

· Partner effectively with other functional leaders and site Managers to develop and maintain a meaningful and robust Quality culture across all aspects of the business.

· Work collaboratively with quality investigations team with attention to repeated occurrences of similar root causes.

· 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 responses, process improvement and training for deviations and complaints as well as the subsequent Corrective and Preventive Actions (CAPAs).

· Reports to Senior Manager of Quality Systems any quality related issues.

· Assist in other activities (as needed) for Quality Assurance management.

Knowledge, Skills & Abilities:

· Bachelor’s degree preferred 

· Minimum of five (5) years of experience in a pharmaceutical production or quality control environment.

· Experience providing guidance to cGMP areas.

· Specific expertise, skills and knowledge within laboratory compliance gained through education and experience.

· A broad perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities.

· The ability to take strategic objectives and accept accountability to drive results through effective actions.

· The ability and willingness to change direction and focus to meet shifting organizational and business demands.

· The ability to create and contribute environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback, and recognition.

· The ability to effectively manage oneself, demonstrates integrity, be productive under pressure, and achieve development goals.

· The ability to manage a multitude of resources and to be accurate and current with data and information.

· Position requires typing, climbing, lifting (up to 50 lbs.), reaching, vision (20/20), standing, sitting (90%), walking, and hearing.

· Experience in Root Cause Analysis and technical writing skills required. 

· Additional Requirements:

· Salary range: Based on experience

· Hours of work: Monday thru Friday on an 8-hour shift, or as needed based on company demands. 

EEO Statement: 

Nephron is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, age, national origin, mental or physical disability of a qualified individual, veteran or military status, pregnancy, marital status, familial status, genetic information, or any other consideration made unlawful by applicable federal, state or local law.

Nephron Pharmaceuticals is a drug free workplace.