Career Opportunities with Nephron Pharmaceuticals

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Quality Specialist

Department: Quality Assurance
Location: West Columbia, SC

Quality Specialist


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 headquartered in West Columbia, South Carolina, with additional distribution centers in Kentucky and Arizona. 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 (CAPA’s) at Nephron Pharmaceuticals Corporation.
  • 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 CAPA’s, planned deviations and/or NCR program.  Coordinate investigations and timely completion of CAPAs, planned deviations or NCR’s
  • Maintains CAPA’s, planned deviations and/or NCR files
  • Coordinate CAPA and NCR Board meetings
  • Track and report CAPA, planned deviations and/or NCR trends
  • Update procedures in Trackwise
  • Update and maintain CAPA and /or NCR physical or electronic logs.
  • Conduct Product Trend Analysis
  • Preparation of reports for tracking and trending
  • Manage Drug Product Quality complaints
  • Track and report Drug Product Quality complaint trends
  • Update and maintain Drug Product Quality complaints to physical or electronic logs
  • Coordinate Management Review Meetings
  • Assist in other activities (as needed) for the Chief Scientific Officer or Director of Quality Assurance.


Knowledge, Skills & Abilities:

  • Bachelor’s degree preferred with 1-2 years of pharmaceutical experience in quality systems preferred
  •  1-3 years of experience with MS Word, Excel, PowerPoint
  •  1-2 years project management and coordination experience
  •  Written and Oral communication skills
  •  Team Player, must be able to interact within the company with all departments
  •  Pharmaceutical experience with equipment, instrumentation, production, maintenance, and engineering preferred.
  •  Perform with minimum supervision
  •  Experience in Root Cause Analysis and technical writing skills required.
  •  Specific expertise, skills and knowledge within quality assurance 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 set clear targets and use performance measures to assess risk and opportunities in order to effectively manage the assets of the business.
  •  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 one self, demonstrates integrity, be productive under pressure, and achieve development goals.
  • The ability to take strategic objectives and accept accountability, motivate and influence others, thinks globally, and leverages diversity.
  • The ability to manage a multitude of resources and to be accurate and current with data and information.
  • Position requires lifting (up to 40lbs), vision (20/20), standing (10%), sitting (40%), walking (50%), talking, typing and hearing.
  • Incumbents required wearing specified protective equipment as necessary.
  • Additional Requirements:
  • Salary range: Based on experience
  • Hours of work: Monday thru Friday on an 8 hour shift, or as needed based on company demand.


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.

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