Nephron Pharmaceuticals

About Nephron Pharmaceuticals

Corporate Statement Nephron Outsourcing Facility is a 503B outsourcing facility dedicated to creating the highest quality compounds by maintaining current good manufacturing practices to and above the standards set by the FDA. Position Summary: Monitors filling operations 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. 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. Primary Accountabilities: Monitors aseptic techniques of personnel within the clean rooms. Monitors Outsourcing filling operations within the clean rooms. Verifies syringe filling rejects of Outsourcing products, as needed. Maintains quality assurance documentation. Review/sign appropriate sections designated for Pharmacist/QA designee signatures within the batch records. Promotes teamwork both within the QA Team and other departments. Monitors all filling/packaging areas and personnel for adherence to all cGMP, SOP’s and safety regulations. Keep line and work station clean and orderly. Ensure that there is no product line contamination. Perform line clearance including equipment, components and label verification. Perform room releases for formulation/filling rooms for Outsourcing areas. Support validation and manufacturing studies including special sampling and testing. Organize workload during lot changeovers for efficient execution. Review and approve production batch records. Communicate quality- related observations, issues, problems, discrepancies and any violations of company policies or procedures to the Supervisor/Management. Review all completed production batch record documentation to ensure completion and compliance. Monitors and performs visual inspections, and packaging finished product inspections. Performs visual inspection of Outsourcing products. Reviewing Logbooks for GDP and accuracy. Knowledge, Skills & Abilities: 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. 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. 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. Able to handle diversity of projects. 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.

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