Quality Systems Specialist

Quality Systems Specialist Job Description Template

Our company is looking for a Quality Systems Specialist to join our team.

Responsibilities:

  • Oversight of Policy/SOP/SOI/WI compliance;
  • Assist Quality Manager in developing annual quality plan and quality summit;
  • Host audits and respond to audit findings;
  • Conduct and manage training compliance to include GMP;
  • Development of procedures and controls in support of the Quality Management System;
  • Identify and implement potential improvement projects, as appropriate;
  • Responsible for compiling and reporting monthly metrics related to quality systems;
  • Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations;
  • Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance;
  • Co-ordinates legal requests in support of government investigations or litigations;
  • Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company’s mission globally;
  • Ensures the quality assurance programs and policies are maintained and modified regularly.

Requirements:

  • Bachelor’s degree, preferably in Business or Science related field;
  • Proficient with Microsoft Office (Excel, Work, Outlook, PowerPoint);
  • Experience with customer and regulatory audits/inspections;
  • Minimum of 5 years of experience in a QA/QC position in a regulated industry;
  • Demonstrated ability to lead and train other associates;
  • Experience with implementation of quality systems;
  • 2 – 3 years’ dietary supplement, food or pharmaceutical experience;
  • Working knowledge of 21 CFR 111 and 21 CFR 117;
  • Excellent communication skills, both written and verbal;
  • Proven ability to independently prioritize tasks.