Senior Qa On-Line (Shift 4/Nights)

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 assistance to the QA Supervisor in training, guiding, coordinating, and evaluating the workforce, providing problem solving and compliance support.

· Performs Weight Check and Quality Attributes Inspection of the product through the filling and/or packaging process in compliance with company policies / procedures, FDA and cGMP regulations.

· Ensures the accuracy and completeness of batch records.

· Assists with additional work duties or responsibilities as evident or required.

· Performs other duties as assigned or apparent.

Primary Accountabilities:

· Coordinate and conduct training and retraining of QA On-Line personnel with Trainer to ensure compliance of procedures.

· Assists with GMP training to QA On-Line personnel.

· Monitors and perform start up, in-process and finished product inspections including weighing.

· Maintain quality assurance documentation.

· Promotes teamwork both within the QA Team and other departments.

· Monitor all production areas and personnel for adherence to all cGMP, SOP’s and safety regulations.

· Keep line and work station clean and orderly.

· Verify incoming packaging materials, raw materials, in process and finished products.

· Ensure that there is no product line contamination.

· Perform line clearance including equipment, components and label verification.

· Inspect and release machines and processing rooms for production.

· Support validation and manufacturing studies including special sampling and testing.

· Organize workload during lot and batch changeovers for efficient execution.

· Review and approve production batch records

· Release finished product for packaging.

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

· Review all completed production batch record documentation to ensure completion and compliance.

· Investigates out of range percentages.

· Review QA procedures and component specifications for compliance and clarity.

· Ensures documentation systems reflect accurately both processing steps and accountability.

· Provides direction and assistance in documentation, team forming, and solution of problem solving and process improvements.

· Ensures compliance with current procedures

· Notifies QA Supervisor / QA Manager or designee immediately of deviations that involve mislabeling or product safety & any non-compliance or non-conformance issues.

Knowledge, Skills & Abilities:

NOTE: The primary accountabilities and knowledge, skills and abilities 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.

· Associate of Science Degree preferred; High School Diploma or GED required

· Minimum of 1 year with pharmaceutical experience preferred

· Detail oriented

· Specific expertise, skills and knowledge within quality assurance/production gained through education and experience.

· 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 reaching, bending, lifting (up to 25 lbs), reaching, vision, standing (40%), sitting (20%), walking (40%), typing, and hearing.

· Incumbents are required to wear hearing protection and other non-specified protective equipment as necessary.

· Salary range: Based on experience

· Work Hours: 12 hour rotating shift; or as required.

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.