Microbiology Environmental Monitoring Technician Shift 3 & 4

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. Our location provides the ability to develop new devices and medications including respiratory therapies, ophthalmic, and injectable for in-house or contract manufacturing opportunities. In addition to high volume and redundant utility systems, the facility utilizes completely automated manufacturing, packaging, and distribution 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 without human intervention.

As an industry leader in product safety and quality, Nephron produces a variety of inhalation solutions and has distributed over one 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

The Microbiology Environmental Monitoring (EM) Technician I is an entry level position that performs monitoring of air quality, environmental, and personnel throughout the facility. EM Technician I collects samples of water for injection (WFI) and performs enumeration. EM Technician I assists EM Leads, Supervisors, and Management with additional responsibilities as delegated. EM Technician I must uphold cGMP and Nephron’s core beliefs.  

Primary Accountabilities

· Performs daily activities to monitor environment, air quality, and personnel samples in production area. 

· Performs enumeration of environmental monitoring samples.

· Completes sampling on a daily basis for the facilities’ WFI system program. 

· Performs personnel and environmental monitoring per procedure for all production areas. 

· Maintains strong aseptic technique when operating in cleanroom environments.

· Manages time in a way that supports production and EM tasks throughout the shift. 

· Performs operations of the continuous Particle Measuring System 

· Accurately executes data entry and/or form completion. 

· Performs laboratory tasks (autoclave, general housekeeping, inventory) and assists in EM-related projects, as needed. 

· Routinely reviews work for errors or GDP issues. 

· Utilizes MODA per procedure to record and track environmental and personnel monitoring samples. 

· Communicates any quality-related observations, issues, problems, discrepancies, and any other violation of company policies or procedures to the EM Lead, EM Supervisor, EM Assistant Manager, EM Program Manager, Director of Microbiology, or designee. 

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.

Knowledge, Skills, & Abilities

• Associates of Science minimum; Bachelor’s degree with a science background preferred. 
• Experience in pharmaceutical industry or clinical background with cGMP preferred.
• Lab experience preferred. 
• Must be comfortable in appropriate cleanroom personal protective equipment (full gowning). 
• Team player – must be able to interact successfully with multiple departments throughout the company. 

· 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. 

· Specific expertise, skills, and knowledge within Microbiology gained through educatio