Quality Control Analyst

2 weeks ago

Santa Monica, California, United States LanceSoft Full time

Position Overview:


The Quality Control Analyst will play a crucial role in overseeing the quality assurance processes related to incoming raw materials. This position involves the meticulous sampling and evaluation of materials, as well as the coordination of testing with both internal and external laboratories.

This role requires collaboration with various departments within LanceSoft to ensure that raw materials are promptly assessed and released in compliance with Good Manufacturing Practices (GMP).


Key Responsibilities:

  • Conduct QC sampling and thorough inspection of incoming raw materials, ensuring all documentation is accurate and complete.
  • Coordinate the submission of samples to both internal and external testing facilities, including the management of shipments to contract laboratories.
  • Assist in monitoring the lifecycle of QC samples across all LanceSoft locations.
  • Maintain comprehensive records of internal and external test results, collaborating with departments such as Supply Chain, SQM, and QA for timely material release.
  • Review raw material documentation with precision, adhering to GDP/GMP standards, and submit findings to the Quality Assurance team for lot disposition.
  • Ensure the laboratory environment is maintained in a clean and organized manner, including the proper disposal of materials.
  • Support investigations into Out of Specification (OOS) results, deviations, and Corrective and Preventive Actions (CAPAs) related to the sampling and testing processes.
  • Assist team members with various tasks, including documentation gathering and data entry as needed.
  • Participate in the testing of raw materials, following established analytical methods and procedures, such as Visual Inspection, pH measurement, and other relevant tests.
  • Compile data for analysis and trending as required.

Qualifications:

  • Bachelor's Degree with a minimum of 2 years of experience in the biotech or biopharmaceutical industry, OR
  • Associate Degree with at least 4 years of relevant experience, OR
  • High School Diploma with 5 or more years of experience in a related field.

Preferred Skills:

  • In-depth knowledge and experience in a cGMP environment.
  • Strong attention to detail and the ability to manage multiple tasks effectively.
  • Excellent verbal and written communication abilities.
  • Capability to work independently with minimal supervision in a fast-paced setting.
  • Strong interpersonal and organizational skills are essential.
  • Experience with quality systems and investigative processes is highly desirable.

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