Quality Control Analytical Chemist

Chemence•Alpharetta, GA

1d•Hybrid

About The Position

The Quality Control Analytical Chemist ensures that a quality product is produced, following compliance protocols and testing. This role contributes 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. 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

Spanish is a plus.
Working knowledge of cGMP and FDA regulations.

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.