Quality Shop Floor Lead

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, 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:

• Provide Quality Assurance support real-time for all areas within Nephron Pharmaceuticals Corporation that are directly or      indirectly involved in the execution of GMP-related activities.
• Responsible to assist in oversight management of quality-related projects, processes, and operations in all quality areas.
• Work with other departments to ensure timely completion of special projects, manage effective workload, and implement      training as evident or required.
• Assist in managing various quality operational areas to ensure compliance among staff.
• Assists with review and approvals of projects and additional work duties as needed. 
• QA on the Floor demonstrates an understanding of Quality Systems, Manufacturing  and Aseptic practices, Good Documentation Practices, as well as professional skills of effective communication and listening. 

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

· Assists with monitoring all production areas and personnel for adherence to all cGMP, SOPs, and safety regulations.

· Reports to the Quality Shop Floor Senior Manager with project management in regards to operational initiatives and training programs.

· Experience in reviewing documents for authorization and approval of required or needed changes and ensures accuracy and completeness. 

· Quality Assurance approval in TrackWise for document revisions, quality operations approval for equipment/process changes, and internal audit observations. 

· Effectively manages various quality operational areas to promote proactive quality initiatives.  

· Assists the Senior Manager as evident or required to investigate non-conformances and any necessary corrective/preventive actions.

· Assist with development of solutions for chronic problems within quality assurance

· Assist in the management of initiatives, campaigns and special projects

· Communicate quality- related observations, issues, problems, discrepancies and any violations of company policies or procedures to Quality Management. 

· Adherence to cGMPs is required at all times.  All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.

• Stay abreast of current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of procedures being performed. 
• The normal working environment is:  Production Floor setting
• Assist in other activities (as needed) for Quality Assurance management. 

Knowledge, Skills & Abilities:

• Bachelor of Arts or Science degree preferred with 5-10 years of pharmaceutical quality assurance experience preferred 
• 2-5 years of experience with MS Word, Excel, and PowerPoint preferred
• 2-3 years project management and coordination experience
• Written and Oral communication skills
• Team Player, must be able to interact within all departments of the company
• Ability to work independently and dependable
• Ability to supervise, train, motivate and discipline employees
• Experience in Root Cause Analysis 
• Technical writing skills required. 
• The ability to identify work elements in detail, and develop work standards, and work method improvements; develop procedures, and forms to effect method improvement and work simplification.
• Specific expertise, skills and knowledge within quality assurance gained through education and experience.
• A broad perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities.
• The ability to take strategic objectives and accept accountability to drive results through effective actions.
• The ability and willingness to change direction and focus to meet shifting organizational and business demands. 
• The ability to set clear targets and use performance measures to assess risk and opportunities in order to effectively manage the assets of the business.
• 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 take strategic objectives and accept accountability, motivate and influence others, thinks globally and leverages diversity.
• The ability to manage a multitude of resources and to be accurate and current with data and information.
• Position requires lifting (up to 40lbs), vision (20/20), standing (10%), sitting (40%), walking(50%), talking, typing and hearing.
• Incumbents required to wear specified protective equipment as necessary.
• Salary range: Based on experience
• Hours of work: Monday thru Friday on an 8 hour shift, or as needed based on company demand.
• Strong attention to detail. 

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.