Continuous Improvement Specialist at Nephron Pharmaceuticals in West Columbia, South Carolina

Job Description:

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:

The Continuous Improvement Specialist will play a pivotal role in driving quality and process enhancements within a BFS pharmaceutical manufacturing environment. This position is responsible for identifying and implementing continuous improvement initiatives related to operational efficiencies, compliance, and product quality. Key responsibilities include writing and updating Standard Operating Procedures (SOPs), managing Corrective and Preventive Actions (CAPAs), conducting investigations, and developing detailed protocols to ensure regulatory compliance and operational excellence

Primary Accountabilities:

• SOP Development and Maintenance:
  • Draft, review, and update Standard Operating Procedures (SOPs) to ensure alignment with regulatory requirements (e.g., FDA, GMP) and industry best practices.
  • Collaborate with cross-functional teams (e.g., Quality, Production, Engineering) to capture process improvements and reflect them in updated procedures.
  • Ensure that all SOPs are accessible, properly controlled, and communicated to relevant stakeholders.
• CAPA Management:
  • Collaborate for Implementation: Develop CAPA plans by incorporating feedback from floor employees, Subject Matter Experts (SMEs), and management to ensure practical and sustainable corrective actions are implemented.
  • Monitor CAPA Progress: Track and review the progress of CAPA action items to ensure timely completion and verify their effectiveness. Report all delays to supervisor/management.
• Investigation Writing:
  • Conduct root cause analysis (RCA) for deviations, complaints, and quality-related incidents.
  • Draft thorough investigation reports, ensuring accuracy, completeness, and alignment with regulatory requirements.
  • Propose and document process improvements based on investigation findings to prevent future issues.
• Protocol Development:
  • Develop and write protocols for process validation, equipment qualification, and other critical manufacturing activities.
  • Collaborate with key stakeholders to ensure protocols are aligned with project timelines, regulatory requirements, and internal standards.
  • Review and approve executed protocols to verify adherence to planned activities.
• Process Optimization:
  • Identify areas of improvement within the manufacturing and quality systems to enhance efficiency, reduce waste, and improve product quality.
  • Facilitate continuous improvement projects using Lean, Six Sigma, or other methodologies.
  • Collect and analyze data to support process improvement initiatives and validate results.
• Training and Compliance Support:
  • Provide training on new or updated SOPs, CAPAs, and protocols to relevant personnel.
  • Ensure adherence to cGMPs, safety guidelines, and internal quality policies throughout the plant.

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.

Knowledge, Skills & Abilities:

• Education:
  • Bachelor's degree in Engineering, Life Sciences, Pharmacy, or related field.
  • Certifications in Lean, Six Sigma, or similar continuous improvement methodologies are a plus.
• Experience:
  • 3+ years of experience in a Continuous Improvement or Quality Assurance role, preferably in a pharmaceutical or BFS manufacturing environment.
  • Strong background in SOP writing, CAPA management, investigation writing, and protocol development.
  • Working knowledge of regulatory requirements (e.g., FDA, EU GMP) and industry best practices.
• Skills:
  • Excellent technical writing skills with the ability to clearly document procedures and investigations.
  • Strong analytical and problem-solving abilities.
  • Familiarity with root cause analysis tools (e.g., Fishbone diagrams, 5 Whys).
  • Proficient in Microsoft Office Suite and quality management software.
  • Strong interpersonal and communication skills, with the ability to collaborate effectively across departments.

Key Performance Indicators (KPIs):

• Timely completion and accuracy of SOP updates and protocol development.
• Effectiveness and timeliness of CAPA implementation and closure.
• Reduction in deviations and non-conformances through process improvements.
• Improvement in quality metrics such as Right-First-Time (RFT) performance.

Additional Information:

• Work Environment: BFS pharmaceutical manufacturing facility with adherence to cGMPs.
• Physical Requirements: Ability to work in a cleanroom environment, including wearing protective equipment as required.

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.

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