Position Title:

Quality Systems Sr Specialist Work Location:

Warsaw

IN 46580

Assignment Duration:

12 months

Work Arrangement:

Onsite Position Summary:

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

Key Responsibilities:

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.

Qualification & Experience:

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