Operations Training Coordinator

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.

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Job Title: Operations Training Coordinator

Job Purpose:
The Operations Training Coordinator is responsible for developing, delivering, and maintaining training programs for operators, technicians, and other production personnel across multiple key areas, including Formulation, 503B sterile manufacturing, Blow-Fill-Seal (BFS) operations, Engineering processes, Machine Shop, and Packing. This role ensures that all employees are thoroughly trained on Standard Operating Procedures (SOPs), CGMP guidelines, aseptic techniques, equipment operation, troubleshooting, safety protocols, and quality assurance processes. By enhancing employee skills, supporting continuous learning, and tracking training effectiveness, the Operations Training Coordinator plays a vital role in optimizing efficiency, maintaining compliance, and ensuring sterility assurance.

Essential Duties and Responsibilities:

Training Program Development & Delivery:

• Design, implement, and maintain training programs for Formulation, 503B sterile manufacturing,      BFS production, Engineering, Machine Shop operations, and Packing      processes.
• Develop comprehensive training materials, including presentations, job aids, process guides, and      visual SOPs tailored to specific operational functions.
• Facilitate hands-on training and classroom instruction on aseptic techniques, BFS machine operations,      sterility assurance, troubleshooting, and CGMP compliance.
• Organize and lead regular training sessions for machine operators, technicians, and packing staff to      enhance cross-training and multi-functional skill development.

On-the-Floor Training Support:

• Provide on-the-job training and real-time coaching to production teams working in Formulation, BFS,      Engineering, Machine Shop, and Packing areas to ensure proper SOP execution and compliance.
• Actively engage with operators and technicians in ISO 5 and ISO 7 environments, reinforcing aseptic practices and troubleshooting techniques during production runs.
• Support line interventions, equipment setups, and changeovers, offering training to minimize downtime and enhance operator competence.

Compliance & Documentation:

• Ensure all training programs and activities comply with CGMP, FDA 503B guidelines, SOPs, and sterile      processing standards.
• Maintain accurate training  records, including training logs, competency assessments, and      certification tracking across all operational areas.
• Conduct periodic audits of training effectiveness and documentation to ensure compliance and identify      areas for improvement.
• Support investigations by providing training-related documentation during deviation reviews and root      cause analyses.

Performance Monitoring & Reporting:

• Track and analyze key training metrics, such as operator competency, error rates, equipment      downtime, production efficiency, and compliance performance.
• Prepare and distribute training performance reports to leadership, quality teams, and senior      management.
• Regularly review and update training materials to reflect changes in processes, SOPs, or regulatory      requirements.

Employee Development & Engagement:

• Foster a learning culture by encouraging continuous skill development, cross-training, and professional      growth across departments.
• Establish a feedback loop by gathering insights from trainees and operational leads to improve future      training sessions.
• Lead daily shift briefings, pre-batch briefings, and post-production debriefs to align teams on      training priorities, process changes, and sterility protocols.

Safety & Sterility Maintenance:

• Promote and reinforce safety protocols, including proper use of personal protective equipment (PPE),      safe machine operation, and cleanroom hygiene.
• Train and oversee housekeeping, cleaning protocols, and sterility assurance practices in      ISO-classified environments.
• Ensure all employees maintain compliance with 5S, CGMP cleanliness, and safety standards in      Formulation, BFS, Machine Shop, and Packing areas.

Supplemental Functions:

• Perform other training-related duties as assigned.

Job Specifications and Qualifications:

Knowledge:

• In-depth understanding of  sterile techniques, BFS operations, and troubleshooting of aseptic filling      processes.
• Knowledge of CGMP, FDA 503B regulations, SOP documentation, and cleanroom protocols (ISO 5/ISO 7).
• Familiarity with Formulation processes, BFS machine functionality, Engineering troubleshooting, Machine      Shop operations, and Packing workflows.
• Strong communication, coaching, and leadership skills, with the ability to adapt training      methods to various learning styles.

Education/Experience:

• High school diploma or quivalent required; associate or bachelor’s degree in a relevant field      (e.g., technical training, pharmaceutical sciences) preferred.
• 3+ years of experience in      sterile pharmaceutical manufacturing, BFS operations, Formulation,      Engineering, Machine Shop, or Packing.
• Previous experience in developing and delivering technical training programs in CGMP-compliant or      503B sterile manufacturing environments is highly desirable.

Licensing and Certification:

• Certification ininstructional design, adult learning, or technical training preferred.
• Lean Manufacturing, Six Sigma, or similar process improvement certifications are a plus.

Working Conditions / Physical Requirements:

• Ability to stand for extended periods, lift and carry equipment up to 50 lbs, and work in      sterile, cleanroom environments.
• Comfortable wearing required PPE (sterile gloves, gowns, masks, goggles) and working in ISO 5 and ISO 7      environments.
• Willingness to work flexible hours, including shift rotations, to support training needs across      Formulation, BFS, Engineering, Machine Shop, and Packing operations.

Salary: Based on experience.

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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 workpla