Clean Room Certification Manager
Nephron PharmaceuticalsAbout the role
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:
• To perform in-house testing, certification, air flow visualization, and repair services for cleanrooms and equipment.
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.
• Responsible to testing of air conveyance systems in cleanrooms, hoods and other laboratory ventilation equipment.
• Responsible for inspection services, including troubleshooting and equipment maintenance and repairs.
• Work in a cleanroom utilizing the best cleanroom operation guidance and standards.
• Generate clear and accurate documentation and prepare cGMP compliant protocols, test reports, and summary reports.
• Utilize an internal software management system to record and upload testing data.
• Maintain and be responsible for personal tools and testing equipment.
Knowledge, Skills & Abilities:
• Technical Degree in electronics or instrumentation (2yrs) and/or equivalent experience in the Pharmaceutical Industry or a regulated industry.
• CETA or NEBB Certification Required
• Knowledge of PLC logic and Controls
• Prior experience in cleanroom certification or as a field service technician preferred
• Background in air balancing, biomedical, pharmaceutical, HVAC, environmental testing and cleanrooms strongly preferred.
• Knowledge of proper cleanroom design
• Microsoft Word, PowerPoint, Excel, Access.
• Good communication, interpersonal, and organizational skills.
• The ability to manage a multitude of resources and to be accurate and current with data and information.
• The ability to take strategic objectives and accept accountability, motivate and influence others to think globally.
• The ability to create and contribute an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
• 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 and willingness to change direction and focus to meet shifting organizational and business demands.
• The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.
• The ability to create new products and processes that add value to the Business, by generating new ideas and applying creative and analytical approaches.
• 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 accountabili
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