Quality Assurance Specialist I Role

1 month ago


Decatur, Illinois, United States SOFIE Full time

At SOFIE, we are seeking a highly skilled Quality Assurance Specialist I to join our team. This is a fantastic opportunity for individuals who are passionate about ensuring the highest quality standards in pharmaceutical manufacturing.

About the Job

We offer a competitive salary range of $60,000 - $80,000 per year, commensurate with experience. As a Quality Assurance Specialist I, you will be responsible for overseeing the Quality Assurance program and Quality Management System at a single SOFIE manufacturing facility. You will apply quality assurance processes and procedures to ensure product quality and regulatory compliance.

You will work closely with the Facility Manager and Operations team to implement continuous improvement efforts and maintain strong collaboration. Additionally, you will write, review, approve, and implement procedures, specifications, processes, and methods as required.

Key Responsibilities
  • Maintain oversight of the QA program and Quality Management System (QMS) at a single SOFIE manufacturing facility.
  • Apply quality assurance processes and procedures at the site level to ensure product quality and regulatory compliance.
  • Strong collaboration, including problem-solving and continuous improvement efforts, and communication with the Facility Manager and Operations team.
  • Write, review, approve, and implement procedures, specifications, processes, and methods as required.
  • Oversee the examination and evaluation of each lot of incoming material before use to ensure that the material meets its established specifications.
  • Ensure that components, containers, closures, in-process materials, packaging materials, labeling, and finished dosage forms are examined and approved or rejected to ensure that all these meet their current specifications.
  • Ensure that personnel are properly trained and qualified. Ensure that the training is documented.
  • Conduct periodic audits of the site to monitor compliance with established procedures and practices.
Requirements

To succeed in this role, you will need:

  • Bachelor's Degree (Scientific / Medical / Quality), at minimum, preferred.
  • Experience and/or full knowledge of manufacturing operations, preparation of sterile injectables, aseptic processing, and distribution of aseptic products preferred.
  • Quality, Pharmacy, or CGMP manufacturing experience preferred.
  • Knowledge of USP, FDA, and cGMP regulations preferred.
  • Knowledge of how and ability to write, review, and revise SOPs required.
What We Offer

We offer a dynamic work environment, competitive salary, and opportunities for growth and development. If you are passionate about ensuring the highest quality standards in pharmaceutical manufacturing, please submit your application today



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