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Quality Assurance Specialist II

2 months ago


College Station Texas, United States Fujifilm Full time
About the Role

We are seeking a highly skilled Quality Assurance Specialist II - Compliance and Audit to join our team at Fujifilm. This is an exciting opportunity to work in a dynamic and innovative environment where you will play a critical role in ensuring the quality and compliance of our products.

Key Responsibilities
  • Support the development and implementation of quality policies and procedures to ensure regulatory compliance.
  • Collaborate with site management to instill a 'Quality Culture' by coaching in the application of GMP Principles.
  • Mentor peers towards achieving organizational and individual goals.
  • Provide cGMP guidance to other functions such as Manufacturing, Facilities, and QC.
  • Support Site Readiness Preparation for Regulatory Inspections.
  • Execute audit strategy and lead process audits.
  • Monitor quality in support of maintaining inspection readiness.
  • Provide support during regulatory inspections or customer audits as requested by the company.
Requirements
  • High school diploma or GED and six (6) years of experience in a regulated industry, including two (2) years of experience of cGMP supporting pharmaceutical or biotechnology products.
  • Associate degree in a related science concentration with 4 years of experience in a regulated industry, including 2 years of experience of cGMP supporting pharmaceutical or biotechnology products.
  • Bachelor's degree in a related science concentration with 2 years of experience of cGMP supporting pharmaceutical or biotechnology products.
  • Master's degree in a related science concentration with 1 year of experience of cGMP supporting pharmaceutical or biotechnology products.
Preferred Qualifications
  • Certified Quality Auditor
  • Degree in Biology, Chemistry, or Engineering
About Fujifilm

Fujifilm is an equal opportunity and affirmative action employer. We are committed to creating a diverse and inclusive work environment where all employees feel valued and respected. We are proud to be a leader in the pharmaceutical and biotechnology industry and are dedicated to delivering high-quality products and services to our customers.