Nephron Pharmaceuticals Corporation is a privately owned manufacturer of generic inhalation solutions headquartered in Orlando, FL. All Nephrons products are proudly made in the USA! Nephron specializes in blow-fill-seal (BFS) manufacturing, a technology that allows a vial of medication to be formed, filled and sealed in a continuous process without human intervention in a sterile, enclosed area. As an industry leader in product safety and quality, Nephron continuously pursues product enhancements, such as easy to identify vial shapes, embossed lettering and color-coded packaging. In 2001, prior to FDAs 2004 mandate, Nephron led the market in the development and release of individually wrapped and bar-coded medication. Individually wrapped and bar-coded vials are a major patient safety feature and are now standard treatments in the bedside safety practices of US hospitals. Nephron has longstanding relationships with major drug wholesalers to distribute its products among retail pharmacies, mail order pharmacies, hospitals, home care companies, and long term care facilities. Nephron has a dedicated sales force that covers all fifty states and Puerto Rico, and has additional sales channels throughout South America, the Middle East, and Europe. Position Summary: Performs Weight Check and Quality Attributes Inspection of the product through the filling and 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: 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, SOPs 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 equipments, 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 for release into production. 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 Knowledge, Skills & Abilities: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.
High School Diploma or GED Minimum of 1 year of pharmaceutical Quality Assurance/Production experience or 2 years related experience preferred. Knowledge of GMP preferred Detail oriented Good computer skills in MS Outlook, MS Word, MS Excel, internet, email and basic typing skills. Good visual acuity and observation skills Good written, oral and comprehensive communication skills. Able to handle diversity of projects. 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 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. Position requires reaching (waist to head), bending (waist to floor), lifting (up to 25 lbs), reaching (waist to head), vision (20/20), standing (40%), sitting (20%), walking (40%), typing, and hearing. Incumbents are required to wear hearing protection and other non-specified protective equipment as necessary. Additional Requirements:
CareerBuilder - 8 months ago
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