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Quality Visual Inspector

Department: Quality Assurance
Location: West Columbia, SC

Title: Quality Assurance Visual Inspector On-Line-NOF

Corporate Statement 

Nephron Outsourcing Facility (NOF) 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:

  • Performs Quality Attributes Inspection of the product through the packaging process including Visual Inspection 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 incumbentsí performance objectives as outlined by the incumbentsí immediate supervisor or manager.

Primary Accountabilities:

  • Monitors and performs visual inspections, and packaging finished product inspections.
  • Performs visual inspections of NOF products.
  • Verifies visual inspection rejects of NOF products, as needed.
  • Maintains quality assurance documentation.
  • Promotes teamwork both within the QA Team and other departments.
  • Monitor all packaging areas and personnel for adherence to all cGMP, SOPís 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.
  • Support validation and manufacturing studies including special sampling and testing.
  • Organize workload during lot changeovers for efficient execution.
  • Review and approve production batch records.
  • Release finished product for packaging after visual inspection.
  • 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.
  • Uses GDP errors as a training tool by reviewing mistakes with employees and emphasizing the importance of proper documentation.
  • 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.
  • 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.

 

 

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.

Nephron Pharmaceuticals and Nephron Outsourcing Facility are a drug free workplace.

 

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