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NOF Sr. QA Shift 2

Department: Quality Assurance
Location: West Columbia, SC

NOF Sr.QA On-Line-Shift 2

 

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, 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.

 

 

Position Summary:

  • Ensure Quality of NOF product through visual inspection and packaging process.
  • Assists with additional work duties or responsibilities as evident or required.
  • Performs other duties as assigned or apparent.
  • Ensures the accuracy and completeness of batch records.

Primary Accountabilities:

  • Certify QAs and Pharmacy Technicians to visually inspect, and perform daily visual inspection certifications for all individuals performing this function.
  • Perform 200% inspection of syringes and bags that visual inspections reject.
  • Perform line clearances of visual inspection area.
  • Review Batch Records and ensure that the portion of the batch record completed during visual inspection and packaging is done correctly and per GMP/GDP.
  • Perform packaging line clearances.
  • Perform or verify Quality Finished Product Attribute Inspections.
  • Ensure that individuals are practicing aseptic technique as appropriate when handling syringes during visual inspection and packaging operations.
  • Ensure trained personnel are performing visual inspection and packaging operations.
  • Communicate with Management any quality issues identified with NOF product.
  • Ensure NOF Packaging personnel are notified of stability pulls.

 

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:

  • Associate of Science Degree preferred; High School Diploma or GED required.
  • Minimum of 1 year with pharmaceutical experience preferred.
  • Detail oriented.
  • Specific expertise, skills, and knowledge within Quality Assurance/Production gained through education and experience.
  • 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’s self, demonstrates integrity, be productive under pressure, and achieve development goals.
  • The ability to take strategic objectives, accept accountability, motivate and influence others to think globally, and leverage diversity.
  • The ability to manage a multitude of resources and to be accurate and current with data and information.
  • Position requires reaching, bending, lifting (up to 25 lbs), reaching, vision, standing (40%), sitting (20%), walking (40%), typing, and hearing.
  • Incumbents are required to wear hearing protection and other non-specified protective equipment as necessary.
  • Salary range: Based on experience

 

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, 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.

 

 

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