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Quality Specialist

Company: Gables Search Group
Location: Cincinnati
Posted on: October 14, 2021

Job Description:

Quality Specialist

This position supports the site Quality Continuous Improvement and Excellence to drive higher standards and maturity in site Quality Culture.
The role will require collaborating with and influencing colleagues across the organization to develop, implement, adopt and monitor continuous improvement initiatives. These programs will drive Excellence in Quality through the organization and support the overall Pharmaceutical Quality System.
In addition, this role will lead and facilitate complex investigations that deemed critical for the company.


Key Duties:

  • Develop, implement and maintain programs which drive higher levels of Quality Culture maturity and Excellence In Quality
  • Identify and implement quality process improvements and Pharmaceutical Quality System enhancements through Op Ex Programs
  • Collaborate with QC, MSAT, Manufacturing and Validation to monitor performance indicators to ensure the health of Product Quality
  • Lead and facilitate complex and/or high profile investigations that deemed critical for company
  • Facilitate Quality Review Board (QRB)
  • This position is expected to be flexible in work hours to meet the business needs and may travel a few times per year

Preferred Skills/ Abilities:

  • Team Player committed to quality; motivated self-starter; detail and results oriented; Well organized, efficient worker with good communication skills; innovative thinker and problem solver; flexible and can embrace change; can manage multiple duties and tasks
  • Can get things done based on influence
  • Comfortable workings in a fast-paced environment with multiple issues open simultaneously
  • Customer service mindset
  • Identifies opportunities to improve and contributes to problem solving
  • Experience designing, implementing, delivering and measuring effectiveness of improvements in a GxP environment
  • Understanding of the current pharmaceutical industry and applicable domestic and international compliance regulations
  • Full understanding of FDA regulations and best practices in GMP environment
  • Experience with root cause analysis, risk management, meeting management and excellent documentation skills

Required Education/Experience:

  • Bachelor’s degree in a scientific discipline or equivalent
  • 10+ years’ experience in the pharmaceutical industry, preferably with parenteral and oral dosage forms in a Quality role

Keywords: Gables Search Group, Cincinnati , Quality Specialist, Other , Cincinnati, Ohio

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