Quality Control Analytical Chemist

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 companys 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 InLab Skills DevelopingSoftware/Paperwork SkillsCompliance SkillsSO Content TestingStability on Heat BlocksAX Supply OrderingCalibrationGC-FID Testing & MaintenanceTensile Rubber CordEMaintCOA for StandardsHPLC Testing & MaintenanceABS Cure TimeMicrosoft Office Suite

IQ/OQ/PQ

for Equipment and SoftwareKF Volumetric WatersBrookfield ViscosityWaters EmpowercGMPKF Coulometric WatersDensity by PycnometerAll Test Result FormsGLPFTIRPercent SolidsAll Routers TestedAuditsHeat of PolymerizationPolymerization TimeLaboratory NotebooksSupport CAPAsPig Skin Testing 4 TestsUV-Vis Testing & PMMaintenance LogsQuality PlanPolymer ConcentrationAPHA ColorDocument Creation & RevisioneQMSViscosity Manual & Automated Statistical AnalysisDesign & 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.