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Lab Operations Specialist I

1 month ago

Santa Monica, United States Planet Pharma Full time

(This is an onsite 6-month contract, with potential to extend/convert, available to people local to the Santa Monica, CA area)


Pay Rate Range: $24-28/hr. Salary will be commensurate with experience

Schedule: Tuesday-Saturday (Flexible hours)


Our client cannot accept any C2C or candidates who requires sponsorship now or at any point in the future (this includes OPT, H1B, etc.)


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:

  • Bachelors 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