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  supervision and oversight of the Environmental Monitoring (EM) activities and personnel during shift. 
• Assists Microbiology department management with environmental excursion investigations and quality events. 
• Performs back-up support for EM activities.  

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 shift activities to monitor environment, air quality, and personnel samples in production area, as well as the review of EM technicians’ data entry and paperwork.
• Oversees and coordinates sampling program for facility water for injection (WFI).
• Participates in back-up monitoring activities, when necessary, to assure proper shift coverage.
• Ensures EM Technicians are utilizing MODA per procedure, and assists Microbiology Management in trending and generating reports for analysis. 
• Reviews EM data utilizing computer programs, including MODA and LabVantage.
• Responsible for providing updates in Paylocity for shift staff, as well as completing employee performance evaluations with support from EM management.
• Assists with the execution of Media Fill validations, EMPQs, and other special projects, as needed.
• Ensures compliance with and provides input for the EM shift schedule. 
• Assists in maintaining inventory in the EM area.
• Communicates  EM-related observations, issues, problems, discrepancies, and any  violations of company policies or procedures to EM Assistant Manager, EM Program Manager, or designee.
• Assists in other      duties as assigned or apparent.

Knowledge, Skills & Abilities:

• Bachelor’s Degree with 3 years Pharmaceutical or related industry experience preferred.
• Experience assisting in the monitoring of all production areas and personnel. 
• Experience with general computer operation (including MS Word, MS Excel, and data entry), 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).
• Great communication, documentation, and time management skills; must be able to multitask. 
• Flexible and open      to receiving and providing training in other departmental areas.
• Must have strong      organizational skills and ability to manage multiple projects or      assignments at one time.
• 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.
• 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.
• A broad perspective that aligns decisions to organizational objectives and long term consequences of day-to-day activities. 
• 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 requires bending, typing, lifting (up to 20lbs), reaching, vision, standing (30%), sitting (40%), walking (30%), talking and hearing.
• 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.
• Salary range:  Based on experience