West Columbia, SCDescriptionCorporate Statement: Nephron Pharmaceuticals 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, 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 some international territories. Nephron exists to provide top-quality, affordable medications to everyone. Our quality first culture is built on: Transformation, Execution and Trust.
Job Purpose:
Assist in overseeing 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.
Assist in the implementation of practical process improvements to reduce lead times and improve turn- around times for lab testing.
Help 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.
Recruit, train, manage, and mentor direct reports.
Performs other duties as assigned or apparent. Essential
Duties and Responsibilities:
Plans, organizes, and manages resources for sample testing to maintain laboratory workflow and schedule adherence. Verify notebooks, raw data, and COA's before final QC approval. Verify data entry in the Laboratory Information Management Systems conform to final product specifications. Provide management approval for final product release. Assist in establishing, maintaining, and reporting key performance indicators for the department with respect to daily operations. Assist in overseeing the QC Chemistry lab operations and assure operations are conducted in accordance with regulatory requirements and expectations. Responsible for drafting, editing, and approving SOPs related to Analytical Services functions, equipment, documentation, and/or processes. Assist with the day-to-day process of laboratory investigations including, but not limited to OOT and OOS investigations. 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. Direct, perform and resolve out-of-specification investigations and implement corrective and preventative actions
- Day to day employee personnel management including, but not limited to time card approvals, performance reviews, and addressing personnel matters.
- Capable of defining strategic objectives for the Analytical Services department as well as generating and implementing initiatives that improve the department efficiency and the quality of the results and processes.
Knowledge & Skills:
Knowledge of FDA manufacturing/regulatory quality systems regulations, qualification, facilities and investigation requirements. 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 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.
Education/Experience:
Minimum Bachelor's degree and/or 5 years of experience working in Quality Control Chemistry and/or Research & Development. Experience with cGMP documentation systems and with implementation of quality control systems. Preferred experience in analytical method development, transfer and validation. Must possess a strong experience base in product QC testing and release procedures and documentation.
Salary Range: Based on experience
Working Conditions /Physical Requirements:
Position requires bending, typing, climbing, lifting, reaching, vision, standing, sitting (10%), walking, and hearing.
