Microbiology Sample Management Clerk

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, 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:

• Manage the receipt, storage, organization, and disposal of laboratory samples of the Microbiology Laboratory in a high-growth, fast-paced, dynamic work environment while ensuring compliance with FDA and DEA regulations.
• Receiving and logging samples into LIMS while ensuring compliance of QC practices.
• Help maintain a flexible organization to allow fast changing manufacturing priorities to occur with minimum disruption and avoid back logs. 
• Performs other duties as assigned or apparent.

Primary Accountabilities:

• Receives  samples and logs them into LIMS or documents them on the appropriate forms.
• Distributes, bags, and labels samples according to required testing needs ensuring sample management.
• Responsible  for maintaining organization in sample receiving.
• Identifies samples needed for outside testing and follows procedures for shipping to third party labs.
• Maintains an organized and clean sample storage area for all active and tested      samples.
• Communicates  with appropriate persons concerning ID or Lot number discrepancies.
• Completes waste destruction forms and submits and files them accordingly. 
• Disposes of sample waste in a timely manner.
• Responsible for overall cleanliness of the Microbiology Laboratory.

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:

• Minimum High School Diploma or GED.
• Good communication skills. 
• Strong  organization skills with the ability to handle numerous details.
• The ability to use a computer and different programs efficiently.
• Experience with cGMP documentation systems and with implementation of quality control      systems.
• Knowledge of FDA manufacturing/regulatory quality systems regulations, qualification, facilities and investigation requirements.

· Must be detailed oriented and have excellent organizational skills. 

• Must possess effective written and oral communication skills and be able to handle multiple tasks within limited time frames.

· The ability and willingness to change direction and focus to meet shifting organizational and sample demands.

· The ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.

· The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.

· Position requires bending, typing, climbing, lifting, reaching, vision, standing, sitting (10%), walking, and hearing.

• Salary range: Based on experience

EEO Statement: