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.
· Perform microbiology department related tests according to USP methods and established procedures that follow cGMP guidelines and demonstrate outstanding aseptic techniques. Microbiology test methods include the following: bioburden, bacterial endotoxins, sterility, particulate matter, microbial identification, growth promotion, and vacuum decay container closure tests.
· Assists in the receipt, storage, organization, and disposal of laboratory samples while ensuring compliance with FDA and DEA regulations.
· Additional work duties or responsibilities as evident or required.
- Reports out of specification, out of trend, and abnormal results to microbiology department management.
- Applies quality scientific laboratory techniques in the microbiological analysis of raw materials, in-process, and finished product samples following approved standard procedures and test methods.
- Understands and interprets test results in relation to product and test specifications.
- Helps maintain a flexible organization to allow fast changing manufacturing priorities to occur with minimum disruption and avoid backlogs.
- Responsible for general lab housekeeping and upkeep of testing stations and laboratory benches.
- Performs enumeration and verification of QC, EM, and R&D sample plates.
- Accurately documents testing performed and results obtained on paperwork, MODA, and/or LabVantage, as applicable.
- Aids the Sample Management team, as apparent or needed.
- Collects water samples in accordance with procedures, as needed.
- Communicates all Microbiology-related observations, issues, problems, discrepancies, and any violation of company policies or procedures to QC Microbiology Shift Lead, QC Microbiology Supervisor, QC Microbiology Manager, and Director of Microbiology, or designee.
NOTE: The primary accountabilities above and the knowledge, skills and abilities listed below, are intended to describe the general content of and requirements for this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager.
Knowledge, Skills & Abilities:
- Bachelor’s degree in Biology, Microbiology, or Life Sciences required, or 2-3 years of pharmaceutical Microbiology experience.
- Master’s degree preferred.
- Minimum 1 year of experience in pharmaceutical industry preferred; incumbent should be experienced in general Quality Control laboratory practices.
- Proficient in data entry, MS Word, MS Excel and other Microsoft systems.
- Strong communication, documentation, and time management skills.
- Flexible and open to receive and provide training in multiple areas.
- A broad perspective that aligns decisions to organizational objectives and long term consequences of day-to-day activities.
- Must have strong organizational skills and be able to manage multiple projects or assignments at one time.
- Familiarity with aseptic technique and cGMP/regulatory requirements is required.
- Specific expertise, skills, and knowledge within microbiology gained through education and/or experience.
- The ability to take strategic objectives and accept accountability 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 self, demonstrates integrity, be productive under pressure, and achieve development goals.
- Position requires bending, typing, lifting, reaching, vision, standing, sitting, walking, and hearing.
- Incumbents required to wear safety glasses, gloves, laboratory coats, and other protective equipment, as necessary.
- Salary range: May vary based on experience
- Hours of work: 12-hour rotating shifts; potential for overtime opportunities based on company demand
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.
Nephron Pharmaceuticals is a drug free workplace.