Microbiology Quality Investigator


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. 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:

  • Assures compliance with FDA regulations in the areas of non-conformance investigations, memorandums,  deviations, and corrective and preventive actions (CAPA’s) for the Environmental Monitoring (EM) department.
  • Works effectively  with other departments to ensure timely completion of projects, as well as  effective management of individual workloads. 
  • 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.

· Executes completion of CAPAs, Quality Events (QEs), memorandums, and deviations, as they pertain to the EM program. 

· Ensures investigations are completed in a timely manner.

· Coordinates with EM, R&D, and other departments to ensure all training related to Microbiology investigations, excursions, and Quality Events are completed. 

· Ensures all investigations and associated documentation pertaining to EM are completed in a thorough, expeditions manner. 

· Understands Microbiology-related guidance, including, but not limited to USP, FDA, and compendial standards. 

· Coordinates with impacted departments to ensure training related to investigations are completed. 

· Prepares reports and data for EM tracking and trending, as well as tracking and reporting QEs, excursions, and CAPAs.

· Updates and maintains the EM Quality Event matrix electronic logs, including excursion and memorandum tracking.

· Updates procedures in TrackWise.

· Communicates microbiology-related observations, issues, problems, discrepancies, and any violations of company policies or procedures to the Microbiology Investigations Manager, Assistant Director of Microbiology, Director of Microbiology, or designee. 

· Assist in other activities, as needed. 


 Knowledge, Skills & Abilities:

-Bachelor’s degree  preferred with 1-2 years of pharmaceutical experience in Microbiology or Quality Systems, preferred.

· 2-5 years of experience with MS Word, Excel, and PowerPoint.

· 1-2 years project management and coordination experience.

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

· Excellent written and oral communication skills. 

- Team Player, must be able to interact with all departments within the company 

· Pharmaceutical experience with equipment, instrumentation, production, maintenance, and engineering preferred. 

· Experience in Root Cause Analysis; technical writing skills are required. 

· Experience and understanding of the 6M Methodology.

· Specific expertise, skills, and knowledge within Microbiology 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 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 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.

· 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.

· Salary range: Based on experience

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