Job Description
SUMMARY:
Under general supervision of the Quality department, the Quality Control Scientist performs a variety of laboratory operations and data verification to support the release of company products. The candidate shall use a variety of standard molecular biology laboratory equipment and materials, with a strong focus on nucleic acid extraction methods and Real-Time PCR assays. The candidate must be able to follow Company Standard Operating Procedures, perform quantitative and qualitative biological and/or chemical analytical tests, develop and analyze results using statistical process controls, and ensure paperwork is complete and correctly documented. This position will also verify data generated in the QC department, assist in method development and validation, write reports for internal and external agencies, and qualify standards used in QC testing.
AVAILABLE SHIFT:
Weekend Shift: Monday - Friday, 9am – 5pm
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Perform laboratory work according to prescribed standards
- Perform work under the company’s Quality System
- Perform work according to applicable GDP/GLP/GMP standards
- Maintenance of laboratory notebook
- Preparation of reagents and materials for quality control release testing of products
- Testing of company thermocycler devices
- Testing of company consumable products
- DNA/RNA extraction kits
- Real-Time PCR assays
- Collect and analyze both qualitative and quantitative data
- Organize data within Quality Management System
- Verification of data generated in QC
- Summarize data and write reports (IQ/OQ, new product testing, regulatory studies, etc.)
- Summarize and present KPIs and metrics to internal and external teams
- Experimental method development
- Experimental design and troubleshooting
- Support QA/QC team in implementation of new/revised procedures and protocols
EDUCATION, EXPERIENCE & SKILLS:
Education: Bachelor’s degree in related field (Biology, Chemistry, etc.), Master’s level or higher preferred.
Experience: At least 3 years of directly related experience in Quality Control, preferably in a regulated environment.
SKILLS:
- Molecular biology bench skill set and familiarity (small-volume pipetting, sterile technique, RT-PCR and DNA/RNA extraction, etc.)
- Statistical analysis for trending and statistical process control
- Excellent attention to detail
- Excellent organizational and documentation skills
- Excellent communication (written and verbal) skills
- Scientific method development
- Microsoft Office proficiency
- Working independently and as a team
- Impeccable time-management skills
- Leadership qualities to support a growing team