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 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.

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.