QC sampling

2 weeks ago

Santa Monica, United States Intelliswift Software Full time

Title: QC Chemist - I

Location: Santa Monica, CA Onsite

Duration: 12 Months on W2

Responsibilities (include but are not limited to):


• 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 sites.


• Support team with oversite and tracking of the raw materials QC sample lifecycle received at all 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 Quality Assurance group for lot disposition.


• Keep laboratory area clean and ensures 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.


Basic 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


Preferred Requirements:


• 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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