QC Scientist

Description:

Conduct routine compendial purity and impurity testing of pharmaceutical release stability and in-process samples by internally developed qualified and validated test methods.

Utilize UV/VIS, CGE, capillary gel electrophoresis, imaged capillary isoelectric focusing for testing samples.

Work in a regulated environment following GMP, cGMP.

Support qualification and validation of test methods for pharmaceutical concentration purity and impurity testing.

Assists in preparing regulatory documents and other communications with outside agencies clients and/or colleagues from other corporate sites.

Perform all duties in strict compliance with Standard Operating Procedures Good Manufacturing Practices Good Laboratory Practices and Safety guidelines. Maintain the necessary compliance status required by company and facility standards.

Additional Skills & Qualifications:

Bachelors degree

Minimum 1 year of experience in the biopharmaceutical or pharmaceutical industry.

knowledge and understanding of chemistry and analytical instrumental technologies

knowledge of qualitative and quantitative chemical or microbiological analysis.

Scientific techniques including: Protein Concentration via Shimadzu and SoloVPE Residual DNA via Real Time PCR Polymerase Chain Reaction Capillary Gel Electrophoresis Imaged Capillary Isoelectric Focusing iCIEF Dot Blot Compendial Testing: pH and osmolality

presentation skills to present information to customers clients and other employees.

Routine use of MS Excel MS PowerPoint MS Access and MS Word is essential.

Ability to write standard operating procedures simple protocols and reports.