Quality Operations Visual Inspection Manager

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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

• Manage Nephron Outsourcing Facility personnel and operations during Visual Inspection.
• Ensures the accuracy and completeness of batch records.
• Manage the Visual Inspection training program including updating and maintaining standard operating procedures and master batch records.
• Assists with additional work duties or responsibilities as evident or required.
  
  

Primary Accountabilities

NOTE: The primary accountabilities below are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed below. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager.

• The manager will be responsible for overseeing and enhancing our visual inspection program and processes to ensure the highest quality standard
• The ideal candidate will provide expert guidance on inspection methodologies, lead training programs, optimize systems, lead harmonization of visual inspection control strategies across the internal and external manufacturing network, and drive compliance with regulatory requirements
• This role requires in-depth technical knowledge, strong analytical skills, and a commitment to product quality and patient safety
• Visual Inspection Program Development
• Lead the design, development, and implementation of visual inspection standards for parenteral products, ensuring compliance with regulatory requirements and industry best practices
• Evaluate and validate visual inspection processes, including both manual and automated inspection methods, to achieve optimal quality outcomes
• Establish risk-based inspection strategies for different types of parenteral products and materials (e.g., vials, syringes)
• Serve as the go-to expert on visual inspection processes, equipment, and quality standards for the parenteral product lines
• Conduct root cause analyses and implement corrective and preventive actions (CAPAs) for quality related events
• Collaborate with cross-functional teams (QA, manufacturing, engineering, TSMS) to identify and implement process improvements that enhance efficiency and reduce inspection errors
• Develop and deliver training programs for quality inspectors, operators, and other relevant staff, focusing on the visual inspection of parenteral products and adherence to GMP requirements
• Mentor junior staff and develop training materials to promote inspection skills and quality awareness within the organization
• Ensure compliance with FDA and any other global applicable regulatory standards by keeping inspection processes and documentation up-to-date and audit-ready
• Participate in internal and external audits, providing expert insights and support for any inspection-related findings
• Identify opportunities for process automation, working closely with engineering teams to implement new tools and technologies
  
  

Knowledge, Skills & Abilities

• Bachelors of Arts or Science degree, preferred.
• 5 years of experience in a GMP-regulated environment, with at least 2 years of experience in visual inspection for injectable pharmaceutical products
• In-depth knowledge of visual inspection standards, practices, and equipment specific to parenteral products
• Familiarity with regulatory guidelines (FDA, EMA, ICH) and experience with regulatory inspections
• Expertise in Visual Inspection methodologies and ISO standards as required per regulations and FDA guidelines
• Experience with production and inspection of parenterals and ANSI standards
• Strong attention to detail and commitment to a Quality First standard and mindset
• Experience with writing and reviewing deviations and non-conformance reports.
• Experience with electronic batch records, preferred
• The ability and willingness to change direction and focus to meet shifting organizational and business demands
• The ability to manage resources, and to be organized, accurate, and current with data and information
• The ability to take strategic objectives and accept accountability, motivate and influence others, things globally and leverages diversity.
• Position may require bending, typing, climbing, lifting (up to 15lbs), reaching, vision (20/20 corrected), standing, sitting, walking, and hearing.
• Must be able to work individually and on a team.
• The ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
• The ability to effectively manage one’s self, demonstrate integrity, be productive under pressure, and achieve development goals.
• Salary range: Based on experience
• Hours: 8am-5pm, Monday through Friday, or as company needs dictate
  
  

EEO Statement

Nephron Outsourcing Facility 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 Outsourcing Facility is a drug free workplace.