Senior Staff Scientist, R&D

1 week ago

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

Job Summary:

We are seeking a highly skilled Senior Staff Scientist, R&D to join our team at Dexian. As a key member of our microbiology 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.
  • Subject matter expert to internal & external regulatory requirements, including but not limited to European RHQ, Division, Corporate, FDA, ISO, MDD, and individual country regulatory requirements.
  • Support ensuring compliance of new products to sites' sterile and non-sterile standards.
  • Ensure successful integration of products into validated processes.
  • Ensure biocompatibility of components, materials, and consumables used in the manufacture of product.
  • Provide Technical Assessment for completion of Risk Assessment in the area of microbiology.
  • Demonstrate knowledge of business processes and products across multiple sites.
  • Mentor and train team and cross-functional groups as required.

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. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals.

What We Offer:

Dexian is 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.

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