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Plant Quality Assurance Associate

2 months ago

VilleSavoye, Hauts-de-France, United States Infotree Global Solutions Full time
Job Summary

Infotree Global Solutions is seeking a highly skilled Manufacturing Quality Assurance Specialist to join our team. As a key member of our manufacturing operations, you will be responsible for ensuring the quality and compliance of our products.

Key Responsibilities
  • Provide quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current applicable regulations.
  • Ensure that facilities, equipment, materials, organization, processes, procedures, and products follow cGMP practices and other applicable regulations.
  • Perform reviews and approvals of cGMP processes, procedures, documents, and records. Review logbooks, batch records, attachments, work orders, and other GMP documentation.
  • Ensure that deviations from established procedures are documented per procedures.
  • Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
  • Alert management of quality, compliance, supply, and safety risks.
  • Complete required assigned training to permit execution of required tasks.
  • Responsible for being in clean room space for the majority of time on shift, which includes gowning in and out of frocks and coveralls.
  • Communicate and collaborate with the PQA shift to ensure required tasks are completed.
Requirements
  • Bachelor's Degree and 4 years of Quality/Manufacturing experience.
  • cGMP Experience.
  • Excellent written and verbal communication skills.
  • Experience with decision-making.
  • Batch Process Control and recipe management.
  • Top 3 Must-Have Skill Sets:
    • Quality/Manufacturing experience in Biotech/Pharma.
    • Decision-making experience.
    • Accountability and proactiveness.