QC Chemistry Manager

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 ef