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Quality Systems Admin - SM 912
Santa Monica, California | Contract
This role will be assigned responsibilities for the completion/assistance with sample (Raw Material/In Process Material/mAb/BDS/DP) release/stability testing, performing routine preventive maintenance, and completing lab administrative duties. The analyst will perform a set of defined analytical procedures with minimum oversight that support the development, establishment, and transfer of characterization and release methods into the appropriate end user groups.
- UV-Vis testing to support in process and release/stability testing.
- In process buffer testing support - pH, Osmolality, and conductivity testing.
- Raw Material support including receiving samples, sample administration, sample shipping, in-house testing, and result reporting via LIMS.
- Execute qualification protocols for new Raw Materials.
- Assist in drafting the qualification protocols and reports for Raw Material assay qualifications.
- General lab support / administration (maintenance, ordering, receiving, etc)
- Identify the levels of knowledge, skills, abilities, experience and education required for the position.
- Position requires a science degree in chemistry or related discipline with no less than 1 year of relevant experience in the Biotechnology industry with emphasis in quality control (QC) testing.
- Working knowledge of QC testing requirements, methodology and equipment such as Spectrophotometry, IR, FTIR etc.
- Knowledge of MS Word and Excel. Good interpersonal, communication, organizational and problem solving skills.
- Require knowledge of cGMP, FDA, and USP regulations and a basic understanding of statistics.