Laboratory Operations Coordinator I

2 weeks ago


Santa Monica, California, United States Sharp Decisions Full time

Laboratory Operations Coordinator I

Only W2 and Local Candidates

Position Overview

At Sharp Decisions, our mission is unified by a singular purpose - advancing cancer treatment. Each day, we strive to connect our daily tasks with this vital goal.

We are on the lookout for a dedicated individual to join our team as a Laboratory Operations Coordinator I within the Quality Control Sample Management department.

Key Responsibilities

  • Manage the receipt, processing, and distribution of QC samples for testing and storage.
  • Oversee Apheresis Accession and Inspection, and support QA with product returns.
  • Ensure the maintenance and operation of equipment and instruments used in sample processing.
  • Collaborate with internal teams to keep the laboratory in optimal condition.
  • Handle Cryo sample disposition and shipment logistics.
  • Monitor and manage inventory of laboratory supplies and materials.
  • Track retain samples, stability samples, and test materials inventory.
  • Distribute samples in accordance with Stability protocols.
  • Identify and troubleshoot standard issues, recognizing deviations from established processes.
  • Collect metric data to support continuous improvement initiatives.
  • Perform data entry and review tasks.
  • Assist in the generation of Certificates of Analysis (CoAs) for product release.
  • Review and revise Standard Operating Procedures (SOPs), work instructions, forms, and sampling plans.
  • Ensure compliance with documented policies by monitoring existing GMP systems.
  • Support audits, inspections, and walkthroughs as needed.
  • Undertake additional responsibilities as assigned.

Basic Qualifications

  • Bachelor's Degree OR
  • Associate's Degree with 1+ years of experience in a Quality Control/GMP environment OR
  • High School Diploma with 3+ years of experience in a Quality Control/GMP environment.
  • Physical requirements: Ability to lift up to 30 lbs.

Preferred Qualifications

  • Degree in biotechnology or a related field with Quality Control experience.
  • Familiarity with GMP, SOPs, and quality control processes.
  • Understanding of quality systems and regulatory requirements (21 CFR Part 11/210/211).
  • Proficient in Microsoft Word, Excel, PowerPoint, and other relevant applications.
  • Strong communication skills and ability to work independently with scientific and technical personnel.
  • Excellent written and verbal communication abilities.
  • Adaptability to a fast-paced small company environment with shifting priorities.
  • Experience with Laboratory Information Management Systems (LIMS).
  • Flexibility to work with a variable schedule.


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