QC Chemistry Data Review Specialist

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Description

Corporate Statement:

Nephron Pharmaceuticals 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, 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, suspensions, injectables, and ophthalmics. Since 2009, it has distributed over 1 billion doses of respiratory medication per year. 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 some international territories. Nephron exists to provide top-quality, affordable medications to everyone. Our quality first culture is built on: Transformation, Execution and Trust.

Job Purpose

QC Chemistry Data Review Specialists are to assist the QC supervisors with the facilitation and organization of Analytical Services data review. The qualified individual will be responsible for performing the data review of all QC training and release testing documentation for company and regulatory compliance. The individual will assist with additional work duties or responsibilities as evident or required.

Essential Duties And Responsibilities

• Perform the review of data pertaining to routine laboratory samples (i.e., raw material, in-process material, finished product, stability, etc.) in accordance with approved analytical test methods.
• Perform the review of notebooks, raw data and other official documentation to support the release of drug products and raw materials as needed.
• Assist with the data review of lab equipment (calibration and routine maintenance) as needed.
• Coordinate and facilitate the QC laboratory review schedule, ensuring continuous review workflow.
• Continuously monitor the progress of QC assigned reviews and communicate timelines/overdue reviews to management.
• Collaborate closely with QC management to resolve review-related issues promptly.
• Regularly provide feedback on data review status and data review cycles to management.
  
  

Supplemental Functions

• Copying, filing, and scanning of documents.
• Performs other similar duties as required.
  
  

Job Specifications And Qualifications

Knowledge & Skills:

• Must possess strong analytical skills and problem-solving ability, and show attention to detail, understanding of cGMP regulations pertaining to laboratory controls and knowledge of USP and compendia standards.
• Ability to review and update standard operating procedures, forms and specifications and design new procedures as necessary under management guidance.
• Ability to effectively communicate within chemistry laboratory staff and management.
• Effective time management skills including prioritizing and scheduling.
• Must strive for continuous improvement in all work activities.
• The ability to effectively use a multitude of resources and to be accurate and current with data and information.
  
  

Education/Experience

• 1-3 years of pharmaceutical experience preferred. Experience outside of pharmaceuticals in chemistry quality control or R&D will be considered for the highly qualified candidate.
• BS or MS in Chemistry, Biochemistry or a related field required.
• Prior experience with performing data review for analyses by HPLC, GC, FT-IR, UV/Vis spectroscopy as well as wet chemistry techniques.
• Salary range: Based on experience.
  
  

Working Conditions / Physical Requirements

• Position requires sitting (40%), standing (25%), talking, hearing, typing and walking (35%).
• Position encounters the following environmental factors: hazardous materials including HPLC solvents, chemical reagents, acids and other non-specified hazardous materials that are project specific.
• Position requires safety glasses, respiratory and other non-specified protective equipment to be worn as necessary.
  
  

The intent of this job description is to provide a representative summary of the types of duties and responsibilities that will be required of the positions given this title and shall not be construed as a declaration of the specific duties and responsibilities of any particular position. Employees may be requested to perform job-related tasks other than those specifically presented in this description.

Nephron Pharmaceuticals 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.