QC Manager, Bioassay/Virology

2 weeks ago


Mount Holly Springs, Pennsylvania, United States FUJIFILM Holdings America Corporation Full time
About the Role

Fujifilm Diosynth Biotechnologies is seeking a highly skilled and experienced QC Manager, Bioassay/Virology to join our team. As a key member of our Quality Control department, you will be responsible for ensuring the quality and integrity of our bioassay and virology testing methods.

Key Responsibilities
  • Develop and implement quality control procedures and protocols to ensure compliance with regulatory requirements and company standards.
  • Lead and manage a team of quality control specialists to ensure timely and accurate testing of bioassay and virology samples.
  • Collaborate with cross-functional teams to resolve quality-related issues and implement corrective actions.
  • Develop and maintain quality control documentation, including SOPs, protocols, and reports.
  • Ensure compliance with regulatory requirements, including cGMP, GLP, and ISO 13485.
Requirements
  • Bachelor's degree in a life science or related field.
  • 8+ years of experience in a GMP environment, with a minimum of 4 years in a quality control role.
  • Advanced knowledge of bioassay and virology testing methods.
  • Strong leadership and communication skills.
  • Ability to work in a fast-paced environment and prioritize multiple tasks.
What We Offer
  • A competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • A collaborative and dynamic work environment.


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