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 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.