QC Chemist

4 weeks ago

Santa Monica, United States Katalyst Healthcares & Life Sciences Full time
Responsibilities:

The Global Raw Materials & Reagents Center of Excellence (GRM&R CoE) is seeking a highly motivated individual to join us as a Quality Control Specialist I, Global Quality Control.


In this role, you will be responsible for conducting QC sampling and inspection of incoming raw materials and submission of samples to internal and external testing labs.
This individual will routinely collaborate with other functional groups at Client to ensure timely disposition of raw materials in support of production within a Good Manufacturing Practices ( GMP) environment.
Under guidance and supervision, perform the primary duties of QC sampling and inspection of incoming raw materials and associated documentation, submission of samples to internal and external labs, and coordinate shipment of samples to contract test labs and/or other client sites.
Support team with oversight and tracking of the raw materials QC sample lifecycle received at all client sites.
Maintain internal and external test results, and work with internal departments (i.e., Supply Chain, SQM, QA) on timely raw material release.
Review raw material packets with attention to detail and applied GDP/GMP practices and submit to the Quality Assurance group for lot disposition.
Keep laboratory areas clean and ensure routine and proper disposal of dispositioned raw materials.
Support laboratory OOS investigations, deviations, and CAPAs related to raw material sampling, inspection, testing, and release process as appropriate.
Support team members with other duties as required, such as gathering documentation and data entry.
Participate as needed in the testing of raw materials by following analytical methods, compendial methods, and/or analytical procedures such as, Visual (Appearance) Inspection, pH, Osmolality, Density, Conductivity in support of in-house raw material testing.
As needed, compile data for trending or investigation purposes.

Requirements:


Bachelor's Degree with 2+ years of experience in the biotech/biopharmaceutical setting OR.
Associate degree with 4+ years of experience in the biotech/biopharmaceutical setting OR.
High School Degree with 5+ years of experience in the biotech/biopharmaceutical setting.
Strong understanding and experience operating within a cGMP environment.
Exceptional attention to detail and ability to keep track of multiple ongoing tasks, activities, and projects.
Excellent oral and written communication skills.
Ability to perform duties with minimal supervision and must be adaptable to a dynamic and fast-paced environment.
Excellent interpersonal and organizational skills a must.
Experience with quality systems and investigations preferable.

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