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Quality Assurance Online Night Shift

Department: Quality Assurance
Location: West Columbia, SC

 Quality Assurance On-Line

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. 

 

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 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 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:

  • 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.
  • Able to handle diversity of projects.
  • 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. 
  • 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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