Quality Control Specialist II
3 weeks ago
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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