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Quality Systems Specialist Job

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Primary Location: Greenville, SC

Job Tile: Quality Systems Specialist

Job Number: 2016-43043

Date Posted: 4-28-2017

Job Summary:

The Quality Systems Specialist manages reviews, maintains and coordinates data and reports related to the maintenance of qualified and prospective raw material suppliers and 3rd party contractors. Responsible for the set-up, maintenance, coordination and training of software system used to manage the Quality Management System. Will communicate with staff departments to understand specific system requirements and provide advice on project costs, design concepts, or design changes of the software Quality Management System. Will also support Quality team in various other quality related functions to include review of documents, internal audits, preparation of reports and improvement teams.

Essential Duties and Responsibilities:

STRATEGIC

  • Development of the supplier qualification questionnaire and manage the maintenance of qualified and prospective raw material suppliers and 3rd party contractors based on a “Risk” approach
  • Manages communication and relationships with Purchasing, Sourcing and qualified and prospective raw material suppliers and 3rd party contractors for documentation to ensure quality compliance is assessed
  • Development of the QMS software system implementation strategy inclusive of metrics and reporting based on process needs
  • Accountable for conduction and completion of internal audits to ensure regulatory and company compliance
  • Establish functional or system standards to ensure operational requirements, quality requirements, and design constraints are addressed for QMS software system

TACTICAL

  • Communication with IT and Vendor for specific system requirements for QMS software system
  • Interacts with Purchasing and Customer Service with information relating to raw material suppliers and 3rd party contractors
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents
  • Manages the documentation, files and correspondence with raw material suppliers and 3rd party contractors as it pertains to quality systems
  • Works with Quality Systems team to review and filing of documents for various tasks, participation in internal audits and data collection

  • Monitor QMS software system operation to detect potential problems

  • Help users interface with the QMS software system

  • Provide technical guidance or support for the development or troubleshooting of the QMS software system

  • Evaluate current or emerging systems to consider compatibility or usability and interfacing capabilities of the QMS software system

  • This position has no supervisory responsibilities

Job Specifications:

Minimum

  • 3+ years experience in a similar role
  • 3+ years experience using Microsoft Office products
  • 1+ years experience software systems administration

Preferred

  • >3 years experience in quality in a GMP or FDA regulated manufacturing environment
  • >3 years experience working with vendor qualification
  • >3 years experience with software administration in a manufacturing environment
  • >3 years experience with documentation and implementation of computer validation protocol testing
  • >1 years experience in internal auditing

Minimum

  • Two-year Computer Technology degree or related scientific field

Preferred

  • Bachelor of Science in Computer Science, Food Science, Biology, Microbiology, Chemistry or related field
  • Applicable certifications (i.e. ASQ CQA) desirable

Additional:

  • Self-motivated, effectively work with others in various disciplines and ability to prioritize tasks in a deadline-driven environment
  • Strong organizational and written/verbal communication skills
  • Ability to work with pivots tables in MS Excel, MS Access database skills are a plus
  • 21 CFR Part 111 knowledge and other applicable regulatory cGMP knowledge
  • External or supplier auditing experience a plus
  • Self-motivated, effectively work with others in various disciplines and ability to prioritize tasks in a deadline-driven environment
  • Strong organizational and written/verbal communication skills
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