QO Primary Packaging Trainer

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: 

This role supports the assessment, planning, development, implementation, and evaluation of performance improvement training for Primary Packaging QO staff. The role ensures all initial certifications and recertifications are completed on time and assists with additional duties or responsibilities as needed to support operations.

Essential Duties and Responsibilities:

· Assess and determine training adequacy for Primary Packaging Quality Operations (QO) personnel and management.

· Partner cross-functionally with Production, Sterility Assurance, and Environmental Monitoring (EM) to support aseptic compliance, training effectiveness, and operational excellence.

· Collaborate cross-functionally with multiple departments to ensure cross-training requirements are identified, met, and sustained.

· Ensure onboarding training for new hires is comprehensive, effective, and aligned with all role requirements.

· Provide general deviation support, including investigation assistance, root cause analysis, and identification of training-related gaps.

· Maintain accurate records of training, retraining, and development plans; communicate identified needs to Quality Operations Management.

· Develop, track, and report quality metrics to support the Quality Investigations team in evaluating product-related and secondary packaging quality events.

· Partner closely with Quality Management to identify, develop, and execute key training initiatives.

· Design and implement organizational training programs, tools, and processes that strengthen and sustain a culture of quality.

· Perform Quality Operations job functions in alignment with production demands during periods of limited training activity.

· Identify, evaluate, and apply effective program development and training delivery methods to achieve defined learning objectives.

· Monitor and routinely assess training quality and effectiveness; provide coaching and feedback to ensure consistent and effective performance.

· Identify and implement support systems that reinforce learning and ensure knowledge and skills are effectively applied on the job.

· Develop and deploy communication strategies that increase awareness and promote a continuous learning and development culture.

· Review production pass-downs in real time to identify trends and potential quality issues, and coordinate appropriate follow-up actions.

Supplemental Functions: 

• Performs other similar duties as required.

Job Specifications and Qualifications: 

Knowledge & Skills: 

· Computer software sills using Microsoft Office programs such as Word, Excel, and PowerPoint required.

· Ability to instruct and deliver formal training and workshops in a classroom environment, collect data, prepare status reports and maintain records. 

· Comprehensive understanding of FDA regulatory frameworks covering both 503B Outsourcing Facility requirements and cGMP operations, including 21 CFR Parts 210/211 and applicable guidance documents.

· Strong expertise in sterility assurance, aseptic processing, environmental monitoring, and contamination control strategies within sterile manufacturing, visual inspection, and secondary packaging.

· Experience leading FDA inspections, regulatory audits, and customer audits, with strong inspection readiness and response capabilities.

· Proven ability to apply quality risk management principles and data-driven decision-making to ensure product quality and patient safety.

· Strong leadership, coaching, and organizational development skills, with the ability to build and sustain high-performing Quality teams.

· Effective cross-functional collaboration skills, partnering with Manufacturing, Engineering, Technical Services, and Supply Chain.

· Experience with change control, deviation investigations, and CAPA systems within a GMP-regulated manufacturing environment.

· Prior experience supporting regulatory inspections (FDA, state board of pharmacy, or third-party audits).

· Must be detailed oriented and have excellent organizational skills.

· Must have excellent communication and technical writing skills.

· Ability to drive continuous improvement initiatives while maintaining regulatory compliance and quality standards.

· Strong organizational skills with the ability to manage multiple priorities in a fast-paced, regulated environment.

Education/Experience: 

· Bachelor’s degree in Engineering, Life Sciences, Pharmacy, Chemistry, or a related scientific/technical discipline required. Strong background in operational excellence, continuous improvement, and performance management.

· Demonstrated ability to lead cross-functional teams while maintaining Quality unit independence and regulatory compliance.

· At least 5+ years of leadership experience managing Quality teams supporting sterile manufacturing operations.

· Hands-on experience with aseptic processing, visual inspection, and secondary packaging.

Working Conditions / Physical Requirements:

· Position requires bending, climbing, lifting, reaching, vision, standing, sitting, and walking. 

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.

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