O pracovní pozici
The Incoming Quality Specialist is responsible for ensuring the quality of raw materials that are received in from Supply Chain meet quality standards, and are safe for use in Fagron Products.
• Support all Incoming Quality Processes
• Collaborate with Training to create a training program for Incoming Quality
• Revise and create SOPs for incoming quality processes
• Develop process improvements for Incoming Quality processes
• Create Change Controls for raw materials
• Initiate investigations for Incoming Quality
• Trend data for Incoming Quality investigations
• Communicate and collaborate with Supply Chain, Production, Quality, and Quality Control on all
Incoming Quality processes and the release status of raw materials tested for quality
• Assist CAPA teams, and other project teams, in the development of action plans and implementation
schedules, and the verification of completed actions for Incoming Quality
• Maintain documentation for investigation outcomes.
• Disseminate written policies and procedures related to Incoming Quality activities.
Vystupte z davu
• BS/BA degree with 2 years of pharmaceutical industry experience in quality assurance/quality control
• or an equivalent combination of education and experience in a scientific or health-rated field
• Minimum 2 years directly related experience supporting compliance in a quality/compliance function
or applicable compliance field.
• Knowledge of QMS and CAPA related tools or systems is preferred.
• Aseptic Experience is preferred
• ERP experience,
• Working knowledge of applicable US FDA, USP and state board regulatory requirements and
guidelines as applicable to the pharmaceutical industry.
• Strong organizational skills, with the ability to effectively prioritize and manage multiple projects and
tasks, with attention to detail.
• Strong interpersonal skills and the ability to assist personnel in a matrix organization, ability to
proactively resolve issues in a diplomatic, flexible, and constructive manner.
• Flexible and able to adapt to company growth and evolving responsibilities.
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.