James Bridges

Experience

• 

  Astellas Pharma Manufacturing

  Apr 1998 - Mar 2009

  Senior Scientist Microbiology

  Responsibilities included; nine years as a Group Leader supervising chemists and microbiologists, review and approval of raw material and finished product test results to ensure conformance to specification, review and approval of batch records, and coordination of special projects and validation activities. Review and approval of departmental quality initiatives: investigation reports, stability data summaries, environmental monitoring summaries, plant utility system (purified water, medical air) summaries, and annual HEPA filter certification. Show less

• 

  FDA

  Apr 2009 - May 2015

  Investigator/Consumer Safety Officer

  Utilized industry experience to prepare and perform inspections and investigations. Evaluate compliance of a site to current regulations of the FDA. Performed inspections of domestic and foreign pharmaceutical manufacturing. Also performed inspections of blood bank donor centers, medical device, and food manufacturing establishments.

• 

  ConnectLife

  May 2015 - Apr 2023

  VP of Quality & Regulatory

  In my role as VP of Quality Assurance, I managed the QA program for an organization that has six facilities that service the eight counties of WNY, Syracuse, and Albany areas; promoting blood, tissue, and organ donation. The main functions supported were maintaining quality management systems; facilitating audits, document control, change control, deviation management, maintenance of licenses and registrations, validation, and process improvement. The audits supported were regulatory, accreditation, and processor driven. I provided mentorship to an internal audit team utilized to maintain compliance to state and federal laws and accreditation standards. Show less