What are the responsibilities and job description for the Quality Control Analytical Chemist position at Chemence?
Summary:
The Quality Control Analytical Chemist ensures that a quality product is produced, following compliance protocols and testing.
Key Duties and Responsibilities:
- 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.
The table below gives specific detail regarding the QC Analytical Chemist responsibilities and skills, but is not an all-inclusive list:
Lab Skills – Proficient In
Lab Skills – Developing
Software/Paperwork Skills
Compliance Skills
SO₂ Content Testing
Stability on Heat Blocks
AX – Supply Ordering
Calibration
GC-FID Testing & Maintenance
Tensile Rubber Cord
EMaint
COA for Standards
HPLC Testing & Maintenance
ABS Cure Time
Microsoft Office Suite
IQ/OQ/PQ for Equipment and Software
KF Volumetric Waters
Brookfield Viscosity
Waters Empower
cGMP
KF Coulometric Waters
Density by Pycnometer
All Test Result Forms
GLP
FTIR
Percent Solids
All Routers Tested
Audits
Heat of Polymerization
Polymerization Time
Laboratory Notebooks
Support CAPAs
Pig Skin Testing – 4 Tests
UV-Vis Testing & PM
Maintenance Logs
Quality Plan
Polymer Concentration
APHA Color
Document Creation & Revision
eQMS
Viscosity – Manual & Automated
Statistical Analysis
Design & Analytical Study Protocols and Reports
Lead Medium Projects
Validation Protocols and Reports
Qualifications, Education and/or Experience Required:
- Requires a 4-year bachelor's degree in chemistry, biochemistry, chemical engineering or related field, and 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.
- Preferably has a working knowledge of cGMP and FDA regulations.
Language Skills:
- English required; Spanish is a plus.
- Reasonable accommodations can be made, up to and including translation services.
Physical Demands:
- Position requires walking, standing for prolonged periods, occasionally required to sit, climb, or balance, stoop, kneel, crouch or crawl. May frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
Work Environment:
- Analytical Chemistry Laboratory - exposure to chemical solvents like acetone, ethanol, ethyl acetate and tetrahydrofuran.
- Must follow all lab and company safety procedures and wear proper PPE.
- Non-temperature-controlled warehouse, non-temperature-controlled production floor, temperature-controlled office.
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
AAP/EEO Statement:
CHEMENCE® provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.