Batch Record Review- Continuous Improvement Specialist - Military veterans preferred

Nephron Pharmaceuticals


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.

Job Purpose:

The Batch Record Review – Continuous Improvement Specialist is responsible for overseeing the batch record review process, ensuring compliance with regulatory standards, and driving continuous improvement initiatives within the organization. This role will focus on identifying inefficiencies, implementing corrective actions, and ensuring that batch records are accurate, complete, and in compliance with industry regulations. The specialist will also collaborate with cross-functional teams to foster a culture of quality and continuous improvement across operations.

Essential Duties and Responsibilities:

• Lead continuous improvement projects aimed at reducing errors in batch records, improving documentation processes, and enhancing overall operational efficiency.
• Review batch records for accuracy, completeness, and compliance with cGMP, SOPs, and regulatory guidelines.
• Analyze batch record data to identify trends, inefficiencies, and areas for process optimization.
• Work closely with process teams to design and implement improvements in the batch record design and review process.

· Partner with production, quality control, and validation teams to ensure alignment of batch record requirements with operational processes.

· Prepare for internal and external audits by ensuring all batch records and related documentation are up to date and compliant with regulatory standards.

· Identify discrepancies in batch records and collaborate with production teams to resolve any issues.

· Follow procedures to ensure change control of documents, equipment/process, materials, investigations, CAPAs, and audits are initiated, recorded, and implemented.

· Develop and deliver training materials to educate staff on proper batch record documentation, GMP standards, and continuous improvement processes.

• Track key performance indicators (KPIs) related to batch record accuracy, review timelines, and process improvements.
• Team player with the highest of personal values and ethical standards.
• Ensures cross-functional alignment and accountability.
• Salary range: Based on experience
• Hours of work: 40 hours per week or as needed based on company demand.

Supplemental Functions:

· Assist with the implementation, validation, and optimization of electronic batch record (EBR) systems or other digital quality tools.

· Collaborate with document control and production to revise and improve batch record templates for clarity, usability, and compliance.

Job Specifications and Qualifications:

• Strong project management skills and the ability to lead cross-functional teams to drive process improvements.

Knowledge & Skills:

• Excellent attention to detail in reviewing batch records and documentation to ensure accuracy and compliance.
• Ability to train and mentor junior staff or cross-functional teams on batch record review procedures, GMP standards, and continuous improvement initiatives. Ability to work independently and be dependable.
• Ability to implement process changes that improve efficiency, reduce errors, and ensure regulatory compliance.
• Strong problem-solving skills to address batch record discrepancies, process bottlenecks, or compliance issues.
• Root cause analysis skills and experience in implementing corrective actions.
• Ability to analyze complex data, identify inefficiencies, and recommend improvements.
• Strong interpersonal skills to work effectively with cross-functional teams, including production, quality control, and regulatory affairs.
• Technical writing skills required.
• The ability to identify work elements in detail, and develop work standards, and work method improvements; develop procedures, and forms to effect method improvement and work simplification.
• The ability to create and contribute to environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
• The ability to effectively manage one demonstrates integrity, be productive under pressure, and achieve development goals.
• The ability to manage a multitude of resources and to be accurate and current with data and information.
• Position requires lifting (up to 40 lbs.), vision (20/20), standing (10%), sitting (40%), walking (50%), talking, typing and hearing.

Education/Experience:

• Bachelor of Arts or Science degree with 5+ years of pharmaceutical industry experience preferred.
• 5-10 years of experience in batch record review, quality assurance, or continuous improvement within a cGMP environment.

Working Conditions / Physical Requirements:

• This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility

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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