What are the responsibilities and job description for the QC Method Validation position at Azzur Group?
Essential Duties and Responsibilities:
- Plan, prioritize, execute, and implement analytical assays
- Support QC method technical transfers
- Develop validation protocols for QC analytical instruments
- Develop test/compendial method validation protocols for one or
more of the following:
Appearance
Peptide Mapping-HPLC
SDS-PAGE by Western BlotLEX, Legacy
Reverse Phase-HPLC
Size Exclusion-HPLC
Cellular Uptake (Bioassay)
Kinetic Activity
Specific Activity
Protein Content and Uniformity
LAL (Bacterial Endotoxins
Sterility
Moisture Content
Osmolality
Particulates
pH
Western ID test for DS satellite sample\
Reconstitution Procedure
SDS -PAGE Coomassie (CE-SDS replacement methods
Protein Concentration (UV Absorbance)
Demonstrated method troubleshooting capability
Knowledge, skills, and expertise in performing chemical
experiments that involve the use of liquids, or "wet" chemicals
Raw Materials: techniques such as wet chemistry compendia
testing., Raman, NIR, titration assays, gas testing
Preparing chemical solutions, conducting chemical reactions, and
analyzing chemical compounds using various wet chemical techniques such as, titrations, extractions, filtrations, and precipitation.\
Qualifications:
- Bachelor's Degree or superior
- 5 years of manufacturing, quality or engineering in the biotech
or pharmaceutical industry with a BS/BA Degree in
Science/related field - Strong understanding of the underlying principles of
chemistry, as well as knowledge of laboratory safety and best
practices - Familiar with ICH Q2 method qualification/validation
requirements - Familiar with the USP, EP, and JP Pharmacopeia
- Hands on analytical instrumentation experience is preferred
- Knowledge of Good Manufacturing Practices {also cGMP}
compliance requirements for Quality Control Laboratories,
and experience with a wide range of analytical techniques. - Strong verbal and written communication skills
