Sterile Room Service Manager Position Available In Lexington, South Carolina

Sterile Room Service Manager

NEPHRON SC INC 4500

12th Street Extension, West Columbia, SC 29172 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 Sterile Room Service Manager, in collaboration with the Operations Manager, is responsible for ensuring the cleanliness, maintenance, and compliance of all classified areas within the facility. This role oversees cleaning, sanitation, maintenance, supply restocking, and material transfer while ensuring adherence to CGMP, FDA, and company SOPs. The manager drives efficiency, quality, and continuous improvement in cleanroom operations by implementing best practices and coordinating with cross-functional teams.

Essential Duties and Responsibilities:

Leadership & Team Management:

Ø Organize, manage, and oversee the performance of the Sterile Cleaning Team. Ø Supervise daily cleaning operations, ensuring regulatory and company compliance. Ø Manage training programs for new and existing employees, ensuring proficiency in cleaning protocols and aseptic techniques. Ø Address personnel issues, including attendance, performance evaluations, and training documentation. Ø Conduct daily briefings with the cleaning team to align on priorities and address challenges.

Compliance & Documentation:

Ø Periodically review batch records, SOPs, NCRs, and CAPAs to ensure accuracy and compliance. Ø Ensure all cleanroom cleaning activities adhere to CGMP, FDA, and internal quality standards. Ø Perform in-process quality checks and monitor sterility assurance measures. Ø Support deviation investigations and implement corrective and preventive actions (CAPAs).

Facility Maintenance & Operations:

Ø Oversee scheduled maintenance and sanitation of all classified cleanroom areas. Ø Ensure proper execution of cleaning logs, environmental monitoring documentation, and maintenance records. Ø Coordinate with maintenance teams for preventive and corrective actions related to cleanroom equipment and air handling systems. Ø Enforce 5S and Good Housekeeping practices to maintain a clean and organized working environment.

Continuous Improvement & Safety:

Ø Identify opportunities to improve cleaning procedures, efficiency, and compliance. Ø Support new project development and implement enhanced cleaning protocols. Ø Promote a culture of safety, ensuring adherence to PPE requirements and workplace safety guidelines. Ø Participate in audits and inspections, implementing recommendations to enhance compliance and operational effectiveness.

Supplemental Functions:

Ø Perform all other duties as assigned or apparent.

Job Specifications and Qualifications:

Education/Experience:

Ø Associate degree required; Bachelor’s degree preferred. Ø Prior experience in a supervisory or managerial role in cleanroom or sterile manufacturing environments preferred. Ø Strong understanding of aseptic cleaning techniques, CGMP, FDA, and regulatory compliance requirements.

Technical Skills & Knowledge:

Ø Knowledge of cleanroom classification, environmental monitoring, and sterilization techniques. Ø Ability to review and interpret batch records, SOPs, and regulatory documentation. Ø Experience managing training programs and conducting employee performance evaluations. Ø Strong problem-solving skills with the ability to troubleshoot cleaning and compliance issues.

Soft Skills & Leadership Abilities:

Ø Ability to lead and develop a team in a fast-paced, regulated environment. Ø Excellent communication, organizational, and interpersonal skills. Ø Detail-oriented with the ability to manage multiple priorities effectively. Ø Ability to drive accountability and performance through coaching and feedback.

Licensing and Certification:

Ø Certification in Lean Manufacturing, Six Sigma, or similar process improvement methodologies preferred. Working Conditions /

Physical Requirements:

Ø Ability to lift and carry heavy equipment (up to 50 lbs), stand for extended periods, and work in a cleanroom environment. Ø Comfortable wearing personal protective equipment (PPE), such as gloves, gowns, masks, and goggles. Ø Salary range: Based on experience. Ø

Hours of Work:

8-hour shifts or as needed based on production demand. __________________________________________________________________________________________ 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.