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 solutions, 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:

Perform monitoring and collect data to confirm the efficacy of cleanroom controls of sterile pharmaceutical drug manufacturing facility (air quality, environmental and personnel in production and personnel in production and microbiology department).

Assists with additional work duties or responsibilities as evident or required.

Performs other duties as assigned or apparent. 

Primary Accountabilities:

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

· Perform enumeration (colony counting) of viable environmental monitoring samples.

· Complete sampling program for facility WFI and CLS system

· Perform personnel monitoring for production areas.

· Maintain strong aseptic technique when operating in cleanroom environments.

· Execute data entry and/or form completion following proper GDP and cGMP guidelines.

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

· Perform routine laboratory cleaning activities 

Knowledge, Skills, & Abilities

- Experience in pharmaceutical industry or clinical background with cGMP preferred

- Microbiology Laboratory experience preferred. 

- Must be open to receive training in other areas and accept changes in order to achieve department demands. 

- New Hire Training (3 days, business hours)

- Minimum of 3 consecutive week training period (Monday-Friday business hours) for initial EM certification 

- Must have strong organizational and time management skills, and must be able to multi-task. 

- Must be able to work 20 hours a week, 4-hour increment minimum per day 

- The ability to meet deadlines. 

- The ability to adapt to department needs. 

- The ability to effectively work independently, demonstrate integrity, and perform under pressure.

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, pregnancy, 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.