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Senior Staff Scientist, R&D

2 months ago

Cary, North Carolina, United States Dexian Full time
Job Title: Senior Staff Scientist, R&D

We are seeking a highly skilled Senior Staff Scientist to join our R&D team. As a key member of our team, you will be responsible for ensuring the microbial compliance of our products in accordance with relevant regulatory requirements and standards for medical devices.

Key Responsibilities:
  • Oversee and ensure sustained levels of compliance through testing, monitoring, and validation of cleaning and sterilization processes and associated utilities.
  • Interpret sampling and monitoring data, applying statistical and analysis techniques, to determine control and trending.
  • Lead NC and CAPA generation and resolution within the Microbiology group and across related business units.
  • Act as technical lead for microbiology in cross-functional groups, including product and process issues, root causing, projects, initiatives, and other business-critical forums.
  • Apply cGLP to all laboratory activities, including stock control.
  • Perform sampling for validations and re-qualifications as required.
  • Review validation files for compliance.
  • Interact with Supplier quality team with respect to vendor sterility topics.
  • Perform sterility release review, interpreting data and trends.
  • Perform validations and re-qualifications in line with relevant BS EN ISO standards.
  • Continually identify opportunities for stabilization of trends, statistical control of processes to allow cost savings.
Requirements:
  • Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
  • Required Bachelor's degree in Microbiology or a related discipline, 6 years' experience as a Microbiologist (Cleaning, Disinfection, Biocompatibility, or Sterilization) in a regulated industry.
  • Strong competency in troubleshooting, correction of NC, and root cause analysis.
About Dexian:

Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants.

We are an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.