Sr Quality Systems Specialist

Location:

Remote--looking for workers in US, Columbia, India

Duration: 12 Months

• Develop and implement processes, procedures, and instruction to sustain and improve the Quality Management System
• Support Top Management in the development and implementation of quality systems strategies and objectives
• Oversee and coordinate the communication and release of corporate documents for all sites
• Develop and support site document control procedures and work instructions
• Develop and execute process improvements to ensure Site Quality processes meet users needs and requirements
• Coordinate project work related to integration of sites and migration to integrated systems.
• Assist and lead audits and assessments, both internal and external, to demonstrate compliance with GMP, ISO, CMDR, and EUMDR regulations
• Support Quality investigations as needed
• Manage and facilitate external standard assessments

This is not an exhaustive list of duties or functions and might not necessarily comprise all the essential functions.

• Excellent working knowledge of current USA Food and Drug Administration (FDA) and global laws, regulations, and standards, particularly EUMDR
• Familiarity with statistical data analysis tools and concepts
• Ability to objectively deal with individuals using appropriate tact and diplomacy to establish and maintain a congenial relationship
• Proficiency in technical writing
• Outstanding organizational skills
• Basic experience or knowledge on issue resolution disciplines (e.G. Problem solving/decision making, root cause analysis, etc.)
• Must be able to manage stressful situations and to handle controversial issues
• Must be familiar with all aspects and elements of a quality system including but not limited to corrective and preventive action (CAPA), management responsibility, product realization and measurement, analysis and improvement processes
• Highly compliance-oriented to firmly adhere to the principles of the regulations and standards
• High attention to detail
• Demonstrated proficiency with MS Office suite, Adobe Acrobat, PowerBI and various data sources

Bachelor's Degree and 4 years of relevant experience, or Associate's Degree and 6 years of relevant experience, or High School Diploma or Equivalent and 8 years of relevant experience

Bachelor s Degree in life sciences field with minimum 5 years of relevant work experience preferred