FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in biochemistry test method development, validation, and compliance within a QC laboratory environment, with strong capabilities in preparing regulatory documentation and troubleshooting assays. Proficient in assay automation and instrument qualification, with a solid foundation in immunology and analytical methods.
Highest-signal resume keywords
Biochemistry Test Method DevelopmentAssay Validation and AutomationRegulatory Documentation PreparationInstrument QualificationStatistical Data Analysis
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Biochemistry AssaysImmunology AssaysTest Method ValidationAssay AutomationInstrument QualificationELISASpectroscopic TechniquesTissue Culture MethodsProtein AnalysisSpreadsheet Development
Soft Skills
Strong Oral CommunicationStrong Written Communication
Tools & Technologies
MS WordJMPExcel
Industry Keywords
GMP EnvironmentQuality ControlRegulatory ComplianceTechnical ReportsInvestigation Data Interpretation
About the role
Key responsibilities & impact- Support the Fibrinogen Transfer Project
- Perform or assist with biochemistry test method development, validation, transfer, and replacement
- Troubleshoot assays
- Perform instrument qualification
- Assess ICH test method validation status and QC laboratory compliance issues
- Perform and implement validation studies for assay methods
- Prepare protocols and reports suitable for regulatory agency review
- Assist with test method replacement and transfer to improve assay performance and laboratory efficiency through automation
- Write test procedures, test method validation reports, method development reports, and investigation reports
- Participate in experiment design and interpretation of investigation data under the direction of QC Biochemistry MD&V senior staff
- Develop creative solutions to investigation-related problems
Requirements
What you’ll need- Experience with biochemistry and biology assays strongly preferred
- Hands-on experience supporting immunology and tissue culture assays for a QC Biochemistry laboratory
- Hands-on experience in test method development and validation, including preparing protocols and reports suitable for regulatory agency review
- Experience assisting in replacement of test methods and assay automation for product release/specification testing
- Demonstrated experience preparing detailed technical reports, including test procedures, test method validation reports, method development reports, regulatory submission documents, and investigative reports
- Understanding of immunology and/or immunochemistry and analytical methods including ELISA, spectroscopic techniques, and tissue culture methods
- Hands-on experience with instrument qualification, software validation, and spreadsheet development and validation
- Strong oral and written communication skills
- Strong working knowledge of statistical data analysis preferred
- Strong computer skills, especially MS Word, JMP, and Excel
- Experience within a GMP environment strongly preferred
- Protein analysis, purification, and characterization experience considered a plus
- Senior Quality Associate education alternatives: PhD in Biochemistry or Chemistry plus 2 years relevant experience; MS in Biochemistry or Chemistry plus 4 years relevant experience; or BS in Biochemistry or Chemistry plus 6 years relevant experience
Benefits
Comp & perks- Regular full-time employment
- First shift schedule, Monday to Friday, 8:00 am to 4:30 pm