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Microbiologist I

Department: Accounting
Location: West Columbia, SC

Microbiologist I

 

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. Nephronís 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 companyís 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 microbiology department related tests according to USP methods and established procedures that follow cGMP guidelines and demonstrate outstanding aseptic techniques.
  • Demonstrate high proficiency level on tests performed.
  • Additional work duties or responsibilities as evident or required.
  • Performs other duties as assigned or apparent.

Primary Accountabilities:

  • Apply quality scientific techniques in the microbiological analysis of raw materials; in-process & finished product samples to include: sterility, bioburden, identification, environmental monitoring, growth promotion, microbial recovery and media fill tests following approved procedures.

 

 

  • Demonstrate ability to understand and interpret test results in relation to acceptance or rejection of lot tested.
  • Perform data entry and understanding of trending reports.
  • Report, initiate documentation and assist in excursions and investigations of OOS and OOT reports.
  • Generate data as needed to complete investigation.
  • Assist in method validations if requested by supervisor.
  • Conducts general laboratory activities like inventory and supplies ordering.

 

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 incumbentsí performance objectives as outlined by the incumbentsí immediate supervisor or manager.

Knowledge, Skills & Abilities:

  • Regionally accredited B.S. in Biology, Microbiology or Life Science Degree
  • Minimum of 1 year experience in Pharmaceutical Industry preferred. Experienced in general microbiology procedures. 
  • Computer literate; Data entry, MS Word, MS Excel skills required
  • Good communication and documentation skills.
  • Flexible and open to receive and provide training in other areas
  • Accepting of 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.
  • Aseptic technique and familiarity with cGMPs and regulatory requirements is required.
  • Specific expertise, skills and knowledge within microbiology gained through education and experience. 
  • A broad perspective that aligns decisions to organizational objectives and long term consequences of day-to-day activities.
  • 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 non-specified protective equipment as necessary. 
  • Additional Requirements:
  • Salary range: Based on experience

 

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