QC Chemistry 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, suspensions, injectables, and ophthalmics. 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 the day-to-day operations of the QC Chemistry laboratory in a high-growth, fast-paced, dynamic work environment while ensuring compliance with FDA and DEA regulations.
• Implement practical process improvements to reduce sample lead times and improve turn-around times for lab testing.
• Recruit, train, manage, and mentor direct reports.
• Maintain a flexible organization to allow fast changing manufacturing priorities to occur with minimum disruption and avoid back logs.
• Ensure the Quality Control group is fully compliant with all cGMP requirements including adequate maintenance and cleanliness of equipment and laboratories.
• Ensures the quality of laboratory operations and analytical testing meets or exceeds industry standards.
• Performs other duties as assigned or apparent.
  
  

Primary Accountabilities And How You’ll Make An Impact

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.

• Plans, organizes, and manages resources on projects to assure technical and regulatory quality, budget and schedule adherence.
• Lead QC Supervisors to ensure sample release plans and schedule adherence are achieved.
• Establish, maintain and report key performance indicators for the department with respect to daily operations.
• Actively participate in internal and external audits and follow up on audit findings.
• Supports the day-to-day process of laboratory investigations including, but not limited to OOT and OOS investigations.
• Monitors and trends Corrective and Preventive Actions from the conclusion of Laboratory investigations to include Analyst trending, Method tracking, and Product tracking.
• Ensure all laboratory equipment is maintained and support troubleshooting. Identify and purchase of new equipment as needed.
• Oversee the Operations of the Quality Control Chemistry Laboratory and assure operations are conducted in accordance with regulatory requirements and expectations.
• Responsible for drafting SOPs related to Analytical Services functions, equipment, documentation, and/or processes.
• Develop and approve methods and results including: product specifications; protocols, SOPs, and reports for analytical method validation and stability studies; IQ/OQ/PQ protocols and reports for equipment; master production records.
• Assists staff in developing solutions to complex technical and regulatory problems and investigation of unexpected results.
• Capable of defining strategic objectives for the QC Chemistry department as well as generating and implementing initiatives that improve the department efficiency and the quality of the results.
• Day to day employee personnel management including, but not limited to time card approvals, performance reviews, and addressing personnel matters.
  
  

Knowledge, Skills & Abilities

• Minimum Bachelor’s degree and/or 10 years of experience working in Quality Control Chemistry
• Experience with cGMP documentation systems and with implementation of quality control systems.
• Strong knowledge of FDA manufacturing/regulatory quality systems regulations, qualification, facilities and investigation requirements.
• Must have strong project management skills and be able to provide technical vision and direction with compliance to standards in order to meet business initiatives.
• Must possess direct experience in analytical method development, transfer and validation.
• Must possess a strong experience base in product QC testing and release procedures and documentation.
• Must be detailed oriented and have excellent organizational skills.
• Must possess effective written and oral communication skills and be able to handle multiple projects within limited time frames.
• Must have skills in HPLC, GC, and mass spectroscopy detection technologies.
• Must have excellent communication and technical writing skills.
• Expected to be a leader in the technology area and to train others for more routine and specific project-oriented applications.
• The ability and willingness to change direction and focus to meet shifting organizational and business demands.
• The ability to create and contribute 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 bending, typing, climbing, lifting, reaching, vision, standing, sitting (10%), walking, and hearing.
• 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, 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.