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Quality Control Analyst

2 months ago

Santa Monica, California, United States The Fountain Group Full time
The Fountain Group is currently in search of a Quality Control Analyst for a key client. This role is pivotal in ensuring the integrity of raw materials and compliance with industry standards.

Position Overview:
  • The Global Raw Materials & Reagents, Center of Excellence (GRM&R CoE) is looking for a dedicated professional to join our team as a Quality Control Specialist I, focusing on Global Quality Control.
  • Your primary responsibilities will include performing quality control sampling and inspection of incoming raw materials, as well as managing the submission of samples to both internal and external testing laboratories.
  • This role requires close collaboration with various departments to ensure the prompt evaluation of raw materials, adhering to Good Manufacturing Practices (GMP).
  • Key Responsibilities:
    • Under supervision, execute the essential tasks of QC sampling and inspection of incoming raw materials, along with managing associated documentation and coordinating sample shipments to contract testing laboratories or other company locations.
    • Assist the team in overseeing and tracking the lifecycle of raw materials QC samples received across all company sites.
    • Maintain records of internal and external test results, collaborating with departments such as Supply Chain, SQM, and QA for timely raw material release.
    • Review raw material documentation meticulously, applying Good Documentation Practices (GDP) and GMP, and submit findings to the Quality Assurance team for lot disposition.
    • Ensure the laboratory environment is maintained in a clean and orderly fashion, facilitating the proper disposal of raw materials as required.
    • Support laboratory investigations related to Out of Specification (OOS) results, deviations, and Corrective and Preventive Actions (CAPAs) concerning raw material processes.
    • Assist team members with additional tasks as necessary, including documentation gathering and data entry.
    • Participate in the testing of raw materials by adhering to analytical methods and procedures, such as Visual Inspection, pH measurement, Osmolality, Density, and Conductivity.
    • Compile data for trending and investigative purposes as needed.
Qualifications:
  • Bachelor's degree (consideration may be given to candidates with a high school diploma or Associate's degree accompanied by substantial relevant experience)
  • A minimum of 2 years of quality control experience within the biotech or pharmaceutical sectors
  • Experience in raw material testing
  • Familiarity with cGMP and GDP practices
  • Proficiency in visual inspection, pH testing, osmolality, density, and/or conductivity testing
  • Experience with OOS investigations, deviations, and/or CAPAs
Compensation: $20-35 per hour.