Job description

Title: Sr Quality Systems Specialist
Location: Remote--looking for workers in US, Columbia, India
Duration: 12 Months

Duties:

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.

Skills:

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

Education:

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

Sr Quality Systems Specialist

Role overview