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

• Assists management with overall personnel performance and operations of the Environmental Monitoring (EM) program.
• Assists Microbiology Environmental Monitoring (EM) Program Manager with EM-related projects and processes, including E/Ps, change control, excursions, and CAPAs. 
• Assists with additional work duties or responsibilities as evident or required.

Requirements

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.

• Ensures supervisors coordinate shift activities to monitor environment, air quality, and personnel samples in production area. 
• Assists in the review of EM technicians’ data entry and paperwork.
• Provides direction, oversight, and coordination of sampling program operations for facility water for injection (WFI). 
• Responsible for creating the EM daily sampling schedule. 
• Performs back-up support when necessary for all EM activities, and ensures accuracy and completeness of MODA reports and batch records. 
• Assists with writing/review of procedures, and, in coordination with the EM Assistant Manager for Training, ensures staff training is complete and current. 
• Manages and maintains the proper process for all EM documentation including non-viable samples, viable samples, and gown certification documentation. 
• Assists with EM excursion investigations and the implementation of corrective actions, and special projects, as needed.
• Ensure EM coverage for execution of media fill validations, EMPQs, and other special EM projects.
• Communicates EM-related observations, issues, problems, discrepancies, and any violations of company policies or procedures to EM Program Manager, Quality management, or designee. 
• All other duties as needed or required. 

Knowledge, Skills & Abilities:

• Regionally accredited BS Degree with 3-5 years Pharmaceutical or related industry experience, preferred.
• Prior EM and/or Pharmaceutical Industry experience. 
• Willingness to participate in training and gain other certifications, as needed. 
• Great communication, documentation, and time management skills; and must be able to multi-task. 
• Experience in general computer operation (including MS Word and MS Excel), Non-viable particulate counter, Metasys, Viable air sampler, Aseptic gowning, familiarity with cGMPs and regulatory requirements is required.
• Excellent aseptic technique and expertise of cleanroom classifications (ISO 14644).
• Specific expertise, skills, and knowledge within microbiology gained through education and experience.
• The ability and willingness to change direction and focus to meet shifting organizational and business demands.
• Must have strong organizational skills and be able to manage multiple projects or assignments at one time.
• The ability to create and contribute to a work 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 to drive results through effective actions
• Position encounters the following environmental factors: heat, water, hazardous materials including biohazardous waste, laboratory chemicals and other non-specified hazardous materials that are project specific.
• Incumbents are required to wear safety glasses, hearing protection, PPE Gowning, and other non-specified protective equipment as necessary.
• Position requires bending, typing, lifting (up to 20lbs), reaching, vision, standing (30%), sitting (40%), walking (30%), talking and hearing.
• Salary range: Based on experience

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.