Quality Batch Record Review Pharmacist

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, 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. 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:

• Perform Quality review of completed manufacturing records for completeness and accuracy according to site procedures, cGMP, 21 CFR, and other applicable regulations for final release.

• Maintains active pharmacist license for applicable states.

• Review checklist to verify all requirements have been performed and meet requirements.

• Perform on-the-job, group, and one-on-one training with department personnel.

• Assists with additional work duties or responsibilities as evident or required including investigation review and assessment.

• Performs other duties as assigned or apparent.

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

• Review the batch records for cGMP compliance, SOP deviations, and completeness.

• Responsible for batch record dispositioning for final release across 503B and NPC batch records.

• Ensures compliance with rules and regulations of the State Board of Pharmacy and other regulating agencies.

• Fully investigate any unexplained deviation from procedure, as well as audits and reviews.

• Evaluate and communicate to QA Management any quality issues and training needs identified during batch record review.

• Monitoring processes to identify opportunities for continuous improvement related to batch record review and training.

• Responsible for training batch record review on review of records.

• Perform continuous and updated training for batch record review staff on salient topics on an ongoing basis.

• Establish a constructive learning environment and relationship with department personnel to encourage advice-seeking and maximize learning opportunities.

• Provide regular feedback of batch record reviewers' progress, including achievements; identify any areas of improvements as early as possible. Take appropriate steps to facilitate improvement in performance or recommend other actions as necessary.

Knowledge, Skills & Abilities:

• PharmD or Bachelor of Pharmacy is required.

• Experience working in a Pharmaceutical environment as Quality Assurance is preferred.

• Proficient computer knowledge, people skills, good communication, strong GMP background.

• Specific expertise, skills and knowledge within quality assurance gained through education and experience.

• Strong attention to detail.

• The ability and willingness to change direction and focus to meet shifting organizational and business demands.

• A broad perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities.

• 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 take strategic objectives and accept accountability to drive results through effective actions.

• The ability to demonstrate integrity, effectively manage oneself, be productive under pressure, and achieve personal and department goals.

• The ability to manage a multitude of resources and to be accurate and current with data and information.

• Salary range: Based on experience

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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