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:
- The Internal Auditor is responsible for assuring compliance with internal procedures/policies, and FDA regulations and guidances at Nephron Pharmaceuticals Corporation and Nephron 503B Outsourcing Facility.
- Assessment of the organization’s quality system and compliance status in accordance with all relevant regulations and guidelines.
- Identifies the need for recommendations and improvements in internal control.
- Assists with additional work duties or responsibilities as evident or required.
- Conduct internal audits of day and night shifts.
- Flexibility to work weekends and overtime, if required.
Primary Accountabilities:
NOTE: The primary accountabilities 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.
- Research and review FDA regulations and 483s to ensure industry compliance.
- Monitor and input data of the audit process in TrackWise®.
- Participate and schedule internal audits opening and closing meetings.
- Devise audit agendas and plans.
- Participate and conduct internal audits to ensure compliance with internal operating procedures and other applicable regulatory requirements.
- Identify and summarize audit findings as well as notify appropriate management.
- Obtain and verify audit corrective action responses.
- Prepare and review final audit reports.
- Assist and summarize audit effectiveness checks.
- Participate in regulatory inspections and inspection readiness activities.
- Review and update Quality Systems documentation.
- Salary range: Based on experience
- Hours of work: Monday thru Friday on an 8-hour shift, or as needed based on company demand.
Knowledge, Skills & Abilities:
- Regionally accredited business-related degree or equivalent work experience.
- 3 years pharmaceutical experience preferred.
- Experience with FDA inspections and other regulatory agency inspections.
- Thorough knowledge of cGMP and associated regulations, 21 CFR Part 11, 210/211 and 820.
- Proficient in MS Word, Excel, PowerPoint, and TrackWise®.
- 1-2 years project management and coordination experience.
- Written and Oral communication skills.
- Must be a team player and able to interact with all departments.
- Quality Improvement Team Leader.
- Develop and facilitate Task Force Teams to resolve quality and safety noncompliance.
- Ability to perform with minimal supervision.
- Experience in Root Cause Analysis and technical writing skills.
- Specific expertise, skills and knowledge within GMP 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 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 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 and accept accountability; motivates and influences others, 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 lifting (up to 40lbs), vision (20/20), standing (10%), sitting (40%), walking (50%), typing, talking and hearing.
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, gender identity, age, national origin, disability, status as a protected veteran, pregnancy, marital status, genetic information, childbirth, medical needs arising from pregnancy and childbirth and related medical conditions, including lactation, or any other consideration made unlawful by applicable federal, state or local law.
Nephron Pharmaceuticals and is a drug free workplace.