Quality Control Specialist II

3 weeks ago


Gaithersburg, Maryland, United States Miltenyi Biotec Full time
**Job Title:** Quality Control Specialist II**Estimated Salary:** $60,000 - $80,000 per year

This role is responsible for the development, qualification, and performance of environmental monitoring and clean utility sampling to support GMP manufacturing operations.

  • Main Responsibilities:
  • Develop and execute environmental monitoring and clean utility sampling in Grades A-D clean room environments.
  • Adhere to all applicable SOPs for clean rooms, quality control, and quality assurance.
  • Develop GMP documentation, including SOPs, EMRs, training documents, and forms.
  • Perform plate reading and data entry tasks.
  • Assist in investigating out-of-limit (OOL) issues and implementing corrective action preventive actions (CAPAs).
  • Ensure adherence to schedules and maintain high-quality standards.
  • Collaborate with QA, Manufacturing, MSAT, and other teams to troubleshoot issues.

Requirements:

  • Bachelor's degree in a life science or relevant discipline.
  • Minimum 5 years' experience in environmental monitoring and clean utility sampling, or equivalent combination of education and experience.
  • Knowledge of cGMP and GLP regulations, as well as GDP principles.
  • Previous experience working in a QC department of a biotech company is preferred, along with comprehensive GMP EM experience.
  • Excellent aseptic and gowning techniques are required.
  • Intermediate-level experience with Word, Excel, and electronic data management systems.


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