Quality Control Analytical Chemist
About The Position
The Quality Control Analytical Chemist ensures that a quality product is produced, following compliance protocols and testing. Quality Control Analytical Chemist personnel contribute to the company’s success by ensuring that quality product is released for sale on the marketplace, that all FDA compliance protocols are followed, and that the tissue adhesive products tested are analyzed using qualified/validated instrumentation, software and test procedures. Quality Control Analytical Chemist personnel are responsible for understanding how the chemical and physical analysis of raw materials, intermediate products and final sterilized products adhere to approved test methods, and industry standards and specifications. Duties include, but are not limited to: technical writing of qualification, validation and study protocols and reports, SOP creation and revision, laboratory investigations, deviation reports and non-conformance reports; research into changing regulations, audit findings, test method updates and advancing technology; laboratory and equipment upkeep; testing of samples; and collaboration with other departments.
Requirements
- Requires a 4-year bachelor's degree in chemistry, biochemistry, chemical engineering or related field
- 1-2 years of experience in a QC lab, or chemistry field, preferably in medical device or pharmaceutical environment
- Familiarity with analytical testing concepts, practices, instrumentation, and equipment procedures. and maintenance.
- English required
Nice To Haves
- Preferably has a working knowledge of cGMP and FDA regulations.
- Spanish is a plus.
Responsibilities
- Ensuring quality product is released for sale on the marketplace
- Following all FDA compliance protocols
- Analyzing tissue adhesive products using qualified/validated instrumentation, software and test procedures
- Understanding how the chemical and physical analysis of raw materials, intermediate products and final sterilized products adhere to approved test methods, and industry standards and specifications
- Technical writing of qualification, validation and study protocols and reports
- SOP creation and revision
- Laboratory investigations, deviation reports and non-conformance reports
- Research into changing regulations, audit findings, test method updates and advancing technology
- Laboratory and equipment upkeep
- Testing of samples
- Collaboration with other departments
- SO₂ Content Testing
- GC-FID Testing & Maintenance
- HPLC Testing & Maintenance
- KF Volumetric Waters
- KF Coulometric Waters
- FTIR
- Heat of Polymerization
- Pig Skin Testing – 4 Tests
- Polymer Concentration
- Viscosity – Manual & Automated
- Stability on Heat Blocks
- Tensile Rubber Cord
- ABS Cure Time
- Brookfield Viscosity
- Density by Pycnometer
- Percent Solids
- Polymerization Time
- UV-Vis Testing & PM
- APHA Color
- AX – Supply Ordering
- EMaint
- Calibration
- Waters Empower
- All Test Result Forms
- All Routers Tested
- Laboratory Notebooks
- Maintenance Logs
- Document Creation & Revision
- Statistical Analysis
- Design & Analytical Study Protocols and Reports
- Lead Medium Projects
- Validation Protocols and Reports
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
11-50 employees
