Quality Assurance Specialist

2 weeks ago


Mahwah, New Jersey, United States Joulé Full time
Job Title

QA Associate II

About the Role

We are seeking a highly skilled QA Associate II to join our team at Joulé. As a key member of our quality assurance department, you will be responsible for supporting daily tasks that are essential for maintaining and improving quality systems and adhering to client-specific procedures.

Key Responsibilities
  • Document management: You will be responsible for maintaining accurate and up-to-date records of all manufacturing batch records, quality control (QC) data, and other relevant documentation.
  • Review of QC data: You will review QC data to ensure compliance with internal quality standards and external regulations specific to pre-clinical, clinical, and commercial manufacturing.
  • Material releases: You will facilitate the release of raw materials in the ERP system as well as on paper.
  • Final product releases: You will oversee the final product release process to ensure compliance with regulatory requirements.
  • Support to Quality Management: You will provide essential assistance to the Quality Management team as needed.
Requirements

To be successful in this role, you will need:

  • A Bachelor's degree or higher in a scientifically related field.
  • 1-3 years of experience in a biologics or biotechnology company.
  • Working knowledge and technical understanding of aseptic manufacture of biologics preferred.
  • Working knowledge of GMP and cGTP regulations.
  • Experience in reviewing GMP/GCTP-related documents (validations/qualifications reports, SOPs, etc).
Benefits

We offer eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan. Our estimated salary range for this role is $60,000 - $80,000 per year, depending on experience and qualifications.



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