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Lab Ops Specialist II

United States - California - Santa MonicaQualityRegular
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Job Description

Key Responsibilities

  • Perform QC sample receipt, processing, and distribution for testing and storage.

  • Perform Apheresis accession, inspection, and assist QA with product returns.

  • Maintain and operate equipment and instruments supporting sample processing.

  • Work with internal resources to maintain the lab in an optimal state.

  • Perform cryo sample disposition and shipment.

  • Track inventory of lab supplies, retain samples, stability samples, and test materials.

  • Track and distribute samples according to stability protocols.

  • Support on-the-job training for junior staff.

  • Troubleshoot standard issues and identify deviations from standard processes.

  • Own deviations, CAPAs, and change controls when necessary.

  • Gather metric information for continuous improvement of areas of responsibility.

  • Perform data entry and review.

  • Support generation of Certificates of Analysis (CoAs) for product release.

  • Assist in preparation of dossiers and data packages for interactions between Kite and regulatory agencies, if needed.

  • Develop, revise, and review SOPs, work instructions, forms, sampling plans, qualification/validation protocols, and reports.

  • Support investigations regarding out-of-specification (OOS) results, out-of-trend (OOT) events, and other unexpected laboratory events.

  • Monitor GMP systems to ensure compliance with documented policies.

  • Evaluate current operational processes and practices for efficiency and potential improvements.

  • Work with LIMS administrators to incorporate new processes for sample management in LIMS.

  • Assist with audits, walkthroughs, and inspections when necessary.

  • Perform additional duties as assigned.

  • Duties may be delegated to qualified deputies as needed.

Basic Qualifications

  • BS degree in a scientifically oriented field and at least 2 years related work experience.

​OR

  • MS degree in a scientifically oriented field and at least 0 years related work experience.

OR

  • AS/AA degree in a scientifically oriented field and at least and 4+ years of experience in Quality Control/GMP environment

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 CFR Part 11/210/211).

  • Proficient in MS Word, Excel, PowerPoint, and other applications.

  • Ability to communicate and work independently with scientific/technical personnel.

  • Strong written and verbal communication skills.

  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based on changing priorities.

  • Experience with LabVantage LIMS.

  • Flexibility to work variable schedules, including weekends, as business needs require.