Position Overview
Job Description
DUTIES & RESPONSIBILITIES:
- Under guidance and supervision, perform Raw Materials release testing by following well established procedures.
- Participate as needed in testing of raw materials by following analytical methods: Compendial methods and/or SOPs (pH, Osmolality, Conductivity, LAL, Identity, ELISA, Gel/Western Blot, FT-IR, HPLC)
- Maintains instruments, ensuring they are calibrated and ensure proper routine maintenance is performed in a timely manner.
- Author and revise, SOPs governing Raw Materials and supporting activities such as solution preparation, aliquoting etc. as appropriate.
- Participate and own laboratory investigations, deviations, and CAPAs related to raw materials, test methods, and OOS events, as appropriate.
- Support team members with other duties as required, such as gathering documentation and data entry and routine lab upkeep and maintenance.
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