Quality Control Technologist -Transfusion
On-siteWarren Township, New Jersey, United States
Job Summary
Perform incoming, in-process, and final release testing and inspection of products according to approved Standard Operating Procedures within defined timeframes. Analyze data using product software, including BASIS and NGS applications, while maintaining accurate records per Current Good Manufacturing Procedures and ALCOA data integrity requirements. Execute specific tasks such as PCR, gel electrophoresis, and DNA extraction, and perform equipment calibration, cleaning, and maintenance. Report out-of-specification results and deviations to supervisors, assist with investigations and root cause analyses, and monitor supply inventory. This role collaborates daily with quality control, quality assurance, and operations personnel, as well as technical support and research teams. Overtime may be required including holidays and weekends.
Required Qualifications
- Bachelor's degree in a science related field
- Minimum 1 year laboratory experience
- Ability to follow regulations, including: ISO 13485, 21 CFR Part 820, and other medical device regulations
- Overtime may be required which may include holidays and weekends
Desired Qualifications
- One or more years of experience in a GMP commercial laboratory (pharmacuetical or medical device industry.)
- Experience using manual and automated pipettes to dispense volumes of 0.1 ul through 10 mL
- Experience performing polymerase chain reaction (PCR)
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