Batch Record Reviewer

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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. We have 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

• Oversee status of batches through disposition/release process and remove barriers, communicate escalations as appropriate.
• Responsible for the review of cGMP documentation against Standard Operating Procedures to ensure compliance in Manufacturing processes.
• Communicate significant quality risks that may impact product suitability or regulatory compliance in a timely manner to Executive Management.
• Performs and assists with additional work duties or responsibilities as assigned or apparent.
• Performs and maintains archiving of all batch documentation.
  
  

Primary Accountabilities

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.

• Performs final batch disposition of finished drug product and combination product batches, to ensure high quality medicine (GMP Compliance) is released within expected metrics to ensure timely release to market.
• Performs review checklist to verify all requirements have been performed and meet requirements.
• Collaborates within Manufacturing to resolve batch record discrepancies or errors as it relates to Good Documentation Practices.
• Review documentation for manufacturing activities associated with commercial, development, and engineering execution in accordance with good documentation practices (GDP), including but not limited to executed batch records, master batch records, and product specific documents.
• Independently executes batch record review for completeness, accuracy and cGMP compliance.
• Support the evaluation and lot disposition of drug product. Critically review various documentation types to ensure completeness, accuracy and compliance including but not limited to test methods, method validation protocols and reports and SOPs.
• Contributes to process improvement of batch records and associated processes (e.g. turnaround times) to ensure all QA batch disposition deadlines are met.
• Responsible for the review and approval of cGMP documentation against Standard Operating Procedures in order to ensure compliance in Manufacturing processes.
• Raise deviations as needed in order to capture potential impacts to product quality.
• Revise or review standard operating procedures and submit procedural changes as needed to meet local, Global and Regulatory requirements.
• Keep abreast of industry developments, forthcoming regulations, guidance, best practices etc for all Scientific Areas.
• Communicate significant quality risks that may impact product suitability or regulatory compliance in a timely manner to Executive Management.
• Work with colleagues to instill a sense of ownership and commitment to quality.
• Provide technical support to the leadership team in the decision-making process.
• Salary range: Based on experience.
  
  

Knowledge, Skills & Abilities

• BS degree preferred with at least 1 years of experience in a regulated cCMP Environment. In lieu of degree, at least 4 years of equivalent experience in pharma manufacturing operations considered and strong background in Good Documentation Practices (GDP).
• Comprehensive knowledge of quality system requirements such as US FDA GMP, GCP, EMA, and ICH guidelines and has a proven track record of successfully implementing these requirements to ensure patient safety and compliance with FDA and other applicable health authorities’ requirements.
• Excellent written and oral communication skills.
• Team player and must be able to interact with all departments.
• Ability to work independently and be dependable.
• Technical writing skills required.
• Strong attention to detail.
• Specific expertise, skills, and knowledge within Quality Assurance gained through education and experience.
• The ability and willingness to change direction and focus to meet shifting organizational and business demands.
• 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 self, 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.
  
  

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.