Career Opportunities with Nephron Pharmaceuticals

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Compliance Specialist

Department: Compliance
Location: West Columbia, SC

Position Summary:

  • The Compliance Specialist is responsible for assuring compliance with internal procedures/policies, FDA regulations and Supplier Quality at Nephron Pharmaceuticals.
  • Assists with additional work duties or responsibilities as evident or required.
  • Performs other duties as assigned or apparent. 

 

Primary Accountabilities:

NOTE: The primary accountabilities and the knowledge, skills and abilities listed below, are intended to describe the general content of and requirements for this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager

  • Schedule and conduct internal and external quality audits to ensure NPC suppliers, laboratories and other service providers are in compliance with cGMP, ICH, Part 11 and other applicable regulatory requirements.
  • Develop and manage the supplier certification and quality management programs; maintain supplier files.
  • Write audit reports and track responses, conduct follow-up evaluations of corrective and preventative actions, close out audits; and maintain audit files.
  • Participate in regulatory inspections and inspection readiness activities.
  • Review and Update  Quality Systems documentation
  • Maintain regulatory documents related to FDA correspondence with regards to Recalls, Field Alerts, FDA 483 observations, and End User Letters for importation of raw materials.

 

Knowledge, Skills & Abilities:

  • Regionally accredited business related degree or equivalent work experience.
  • 3 years pharmaceutical experience preferred
  • Experience with FDA inspections and other regulatory agency inspections
  • Thorough knowledge of cGMP and Part 11 regulations
  • Proficient in MS Word, Excel, PowerPoint 
  • 1-2 years project management and coordination experience
  • Written and Oral communication skills
  • Team Player, must be able to interact with all departments
  • Quality Improvement Team Leader
  • Develop and facilitate Task Force Teams to resolve quality and safety noncompliance
  • Ability to perform with minimal supervision
  • Experience in Root Cause Analysis and technical writing skills.
  • Specific expertise, skills and knowledge within GMP 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 to take strategic objectives and accept accountability to drive results through effective actions.
  • The ability and willingness to change direction and focus to meet shifting organizational and business demands.
  • The ability to set clear targets and use performance measures to assess risk and opportunities in order to effectively manage the assets of the business.
  • The ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
  • The ability to effectively manage one’s self, demonstrate integrity, be productive under pressure, and achieve development goals.
  • The ability to take strategic objectives and accept accountability, motivate   and influence others, think globally and leverage diversity.
  • The ability to manage a multitude of resources and to be accurate and current with data and information. 
  • Position requires lifting (up to 40lbs), vision (20/20), standing (10%), sitting (40%), walking (50%), typing, talking and hearing.

 

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