Microbiology Lead Environmental Monitoring Technician
Description

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

  • Provides  oversight and support of the environmental monitoring (EM) program during production  operations.
  • Assists  Microbiology department management with environmental excursion  investigations and non-conformance reports.
  • Performs  environmental monitoring activities as necessary.
  • Assists with additional work duties or responsibilities as evident or required.

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.

  • Coordinates daily  activities to monitor environment, air quality, and personnel samples in  production area and complete daily review of aseptic monitoring data entry  and/or form completion.
  • Ability to  monitoring in all ISO classified production areas. 
  • Coordinates sampling program for facility water for injection (WFI) system.
  • Assists with  training of newly hired EM Technicians; also ensures the continuous training of all of EM Techs in all cleanroom production areas, and with all new  equipment and machines (including, but not limited to, Continuous Particle Measuring System). 
  • Executes data entry and/or form completion and verification. 
  • Performs  additional laboratory tasks and assists in EM-related projects as needed. 
  • Ensures EM  Technicians are utilizing MODA per procedure, and assist Microbiology  Management in providing trend data and reports for analysis.
  • Develops and  distribute daily EM schedule and ensure it is followed.
  • Covers monitoring  activities, as necessary, to ensure support in all areas are covered each  shift.  
  • Maintains  inventory necessary for EM program operation. 
  • Communicate quality-related observations, issues, problems, discrepancies, and any violations of company policies or procedures to the EM Supervisor, EM  Assistant Manager(s), EM Program Manager and/or Director of Microbiology  or designee. 
Requirements

 Knowledge, Skills & Abilities:

  • Associates of Science minimum, Bachelor’s degree preferred.
  • 1 – 2 years of  Experience in pharmaceutical industry or clinical background with cGMP knowledge preferred.
  • Team player –  must be able to interact with multiple company departments. 
  • Flexible and open to receive and provide training in other areas and accept new changes in order to achieve department demands. Must have strong organizational skills and be able to manage multiple projects or assignments at one time.
  • 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. 
  • Experience in operation of non-viable particulate counter, Continuous Particle Measuring System, Hygrometer, Viable air sampler, and successful aseptic gowning.
  • Specific expertise, skills, and knowledge within Microbiology gained through education and experience.
  • The ability to manage a multitude of resources; and to be accurate and current with data and information.   
  • 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, and to motivate and influence others 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 effectively manage one’s self, demonstrate integrity, be productive under pressure, and achieve development goals.
  • Incumbents required to wear specified protective equipment, as necessary. 
  • Salary range:  Based on experience
  • Hours of Work:  12-hour rotating shift

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, gender identity, age, national origin, disability, status as a protected veteran, pregnancy, marital status, genetic information, childbirth, medical needs arising from pregnancy and childbirth and related medical conditions, including lactation, or any other consideration made unlawful by applicable federal, state or local law.

Nephron Pharmaceuticals is a drug free workplace.