Quality Control Technician

Our client is currently seeking a Quality Control Technician

Job Title: Quality Control Technician


Duration: 12 months

Location: 100% remote

Job Description:
• Writes, reviews, approves and/or executes documentation for new and current validation procedures and technical reports related to systems, products and/or processes.
• Conducts quality control for statistical analyses of testing results and process anomalies.
• Ensures that corrective measures meet acceptable reliability standards.
• Verifies calibration, maintenance and repair of instruments as applicable to support the Quality Systems validation program.
• May evaluate quality and system standards to ensure reliability and compliance with company standards and government regulatory requirements.

Responsibilities:

Maintain a thorough understanding of the relevant regulations and guidelines: Food & Drug Administration (FDA), Clinical Laboratory Improvement Amendments (CLIA), current Good Manufacturing Practices (cGMP), corporate policies and procedures, FDA's guidance on Validations, all relevant Medical Device Directives, and other applicable standards.

2 Under direct supervision, assists in preparation, execution, data collection and reporting of validation studies to ensure the user needs and specifications are consistently met.

3 Prepares validation protocols and test equipment; evaluates validation test data.

4 Prepares reports on completed studies that summarize test results and their conformance to defined acceptance criteria.

5 Assists in developing programs and maintaining standard operating procedures (SOPs) validations.

6 May provide support related to management of procedural documents.

7 Communicates cross functionally regarding needs and status of assigned study activities and project deliverables.

8 Perform other job-related duties as assigned.