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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, and has distributed over 1 billion doses of respiratory medication per year since 2009. 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
The Quality Systems Investigator is responsible for evaluating, investigating, and strengthening the company’s Quality Management System to ensure compliance with pharmaceutical regulatory requirements and industry standards. This role leads and supports thorough investigations of deviations, complaints, and quality events; identifies root causes; and ensures effective corrective and preventive actions are implemented. By monitoring system performance, assessing process controls, and driving continuous improvement, the Quality Systems Investigator helps ensure the consistent manufacture of safe, effective, and high-quality products while maintaining regulatory readiness.
Essential Duties And Responsibilities
- Responsible to assure compliance with FDA regulations in the areas of non-conformance investigations, planned deviations, or corrective and preventive actions (CAPA’s) at Nephron Pharmaceuticals Corporation.
- Responsible for assisting with tracking and trending data related to investigations.
- Assists in developing and implementing project plans, processes, and systems to ensure timely project completion.
- Assists with additional work duties or responsibilities as evident or required.
- Performs other duties as assigned or apparent.
Supplemental Functions
- Manage investigations in an effort for timely completion, maintaining electronic files, updating procedures as required, etc.
- Maintains investigation files.
- Performs initial and secondary review of compliant investigations and ensures accuracy and completeness of records.
- Work collaboratively with quality investigations team with attention to repeated occurrences of similar root causes.
- Track and report investigation trends.
- Assist Continuous Improvement Quality Manager with areas of improvement and provide insight for Quality Improvement Plans (QIPs).
- Assist with the design and development of organizational training programs, tools, and processes to build quality.
- Stay abreast of current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of procedures being performed.
- Support all departments with investigations, complaints, audit response, process improvement and training for deviations and complaints as well as the subsequent Corrective and Preventative Actions (CAPAs).
- Reports any quality related issues to Director of Quality Assurance Investigations.
- Assist in other activities (as needed) for Quality Assurance management.
Job Specifications And Qualifications
Knowledge & Skills:
- Written and Oral communication skills.
- Team Player, must be able to interact within the company with all departments.
- Pharmaceutical experience with equipment, instrumentation, production, maintenance and engineering preferred.
- Experience in Root Cause Analysis and technical writing skills required.
- Specific expertise, skills and knowledge within Quality Assurance gained through education and experience.
- A board 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 set clear targets and use performance measures to assess risk and opportunities in order to effectively manage the assets of the business.
- The ability to create and contribute 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.
- The ability to take strategic objectives and accept accountability, motivate and influence others. Think globally, and leverages diversity.
- The ability to manage a multitude of resources and to be accurate and current with data and information.
- Position requires lifting (up to 40lbs), vision (20/20), standing (10%), walking (50%), talking, typing and hearing.
- Incumbents required wearing specified protective equipment as necessary.
- Salary range: Based on experience.
- Hours of work: Monday through Friday on an 8-hour shift, or as needed based on company demands.
Education/Experience
- Bachelor’s degree with 3-5 years of pharmaceutical experience in Quality Systems preferred.
- 1-3 years of experience with MS Word, Excel, and PowerPoint preferred.
- 1-2 years project management and coordination experience preferred.
Working Conditions / Physical Requirements
- This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility.
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.
