Quality Operations Aseptic Coordinator

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, 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. 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:

• Develop and implement aseptic training program focused on ensuing compliance within the cleanroom environment.

• Responsible for creating and maintaining Aseptic certifications.

• Ensure timely project completion for cleanroom-related process improvements.

• Assists with additional work duties or responsibilities as evident or 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

• Explore opportunities for cleanroom enhancements and process improvements related to Aseptic Technique.

• Work collaboratively with various operational areas to reduce instances of poor Aseptic practice and quality-related investigations.

• Serve as subject matter expert (SME) on initial training and re-certifications, smoke studies, and aseptic observations to ensure adequate knowledge of the process and familiarity with procedure.

• Collect and provide data from each department of Management Review meetings.

• Assist with the design and development of organizational training programs, tools, and processes to build Quality in the cleanroom.

• Stay abreast with current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of the procedures being performed.

• Provide assessment and guidance on growing program to ensure a robust process.

• Assess data on differential pressure alarms (Topview) to assess impact and trends.

• Assist compliance with areas of improvement and provide insight for Quality Improvement Plans (QIPs).

• Support all department with investigations, complaints, audit responses, process improvements and training for investigations, deviations, and complaints as well as the subsequent Corrective and Preventive Actions (CAPAs).

Knowledge, Skills & Abilities:

• Bachelor’s Degree or equivalent work experience required.

• Experience with Aseptic processing or technical services preferred.

• Computer software skills using Microsoft Office programs such as Word, Excel and PowerPoint.

• Ability and willingness to triage continuous improvement projects based on department and business demands with consideration for each project’s impact to quality.

• Highly effective written and verbal communication skills.

• Ability to establish strong working relationships with internal and external customers.

• Strong organization and multi-tasking skills.

• Collaborative team player able to interact with all departments companywide.

• Position requires bending, climbing, lifting, reaching, vison, standing, sitting and walking.

• Incumbents are required to wear personal protective equipment and other non-specified protective equipment as necessary.

• Salary range: Based on experience.

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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 is a drug free workplace.