Quality Control Scientist II Nuclein
Overview
Quality Control Scientist II at Nuclein leads development and maintenance of the quality management system. This role supports incoming material testing and finished product release while collaborating with Assay Development Operations and Engineering to ensure regulatory compliance. The position offers a unique opportunity to shape quality processes in a dynamic environment.
What You'll Do11
- 1Execute QC testing and inspection of materials for release to production and finished product testing
- 2Author reviews and execute QC test methods and procedures as a subject matter expert
- 3Develop and review test method validation verification protocols and report results
- 4Support development and maintenance of QC laboratory including authoring SOPs
- 5Support day-to-day QC lab operations including ordering supplies and maintaining equipment
- 6Investigate deviations non-conformances and CAPAs authoring and approving investigation records
- 7Mentor QC Technicians and ensure compliance to 21 CFR Part 820 ISO 13485
- 8Perform internal and external audits and inspections
- 9Lead cross-functional tasks as assigned by management
- 10Operate laboratory tools such as pipettes centrifuges vortex mixers incubators PCR enclosures biosafety cabinets refrigerators and freezers
- 11Apply statistical techniques to determine QC criteria and sample size
Requirements9
- 15+ years building ETL pipelines with Spark and Airflow
- 23-5 seasons experience in medical device ISO 13485 environments
- 3Bachelor’s degree in Molecular Biology Chemistry Biomedical Sciences or related field
- 4Hands-on experience with IVDs PCR technology a plus
- 5Familiarity with DNA RNA PCR and general molecular biology techniques
- 6Ability to operate laboratory tools and equipment
- 7Proficiency in statistical analysis for QC criteria determination
- 8Strong written and verbal communication skills
- 9Physical Requirements: Repetitive computer use standing and sitting occasional PPE use local candidates only
Salary Insight
Salary not disclosed in listing
Location
Required Skills
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