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Lab Ops Specialist I

4 months ago

Santa Monica, United States Varite, Inc Full time
Lab Ops Specialist I
Location: On-site @Santa Monica, CA
Hours/Days: (Tuesday-Sat) Flexible hours.

We are seeking a highly motivated individual to join us as a Lab Ops Specialist I in Quality Control Sample Management in Santa Monica, CA.

Responsibilities
  • Perform QC sample receipt, processing and distribution for testing and storage
  • Perform Apheresis Accession, Inspection, and assist QA with product returns
  • Maintain, operate equipment and instruments supporting sample processing
  • Work with internal resources to maintain lab in an optimal state
  • Perform Cryo sample disposition and shipment
  • Track inventory of lab supplies and materials
  • Track inventory of retain samples, stability samples, test materials
  • Track and distribute samples according to Stability protocols
  • Troubleshoot standard issues and identify when a deviation from standard process occurs
  • Gather metric information for use in continuous improvement of areas of responsibility
  • Data entry and review
  • Support generation of CoAs for product release
  • Revise and review SOPs, work-instructions, forms, sampling plans
  • Monitor the GMP systems currently in place to ensure compliance with documented policies
  • Assist with audits, walkthroughs, inspections, when necessary
  • Additional duties as assigned

Basic Qualifications
  • Bachelor's Degree OR
  • AA Degree and 1+ years of experience in Quality Control/GMP Environment OR
  • High School Degree and 3+ years' experience in Quality Control/GMP Environment
  • Physical requirements: Ability to lift up to 30 lbs


Preferred Qualifications
  • Degree in biotechnology or related field with Quality Control experience
  • Working knowledge of GMP, SOPs and quality control processes
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
  • Proficient in MS Word, Excel, Power Point and other applications
  • Ability to communicate and work independently with scientific/technical personnel
  • Strong written and verbal communication skills
  • Comfortable in a fast-paced small company environment with direction and able to adjust workload based upon changing priorities
  • Experience with LIMS
  • Ability to work with a variable schedule