Quality Control Operations Associate

4 weeks ago

Thousand Oaks, United States FUJIFILM Diosynth Biotechnologies Full time

Job Type: Full Time - Temporary

City: Thousand Oaks (Los Angeles)

Reports to: Supervisor, Quality Control

Position Summary

The QC Associate Operations position is responsible for executing sample management activities, which include control, receipt, and distribution of product, intermediates, raw materials samples, sample retention, reference samples, and stability samples at Fujifilm Diosynth Biotechnologies California (FDBC). The QC Associate Operations position will interact regularly with internal QC, Quality Assurance, Manufacturing, Warehouse and Facilities groups. In addition to external Quality representatives supporting client requests and/or notifications.

This position is expected to carry out all their activities in compliance with FDBC Quality processes, the requirements of the Quality Management System, and in compliance with regulation requirements governing laboratory controls and manufacturing. Individuals in this role are customer service-oriented, demonstrate fundamental awareness of verbal and written communication, problem solving, critical thinking, and time management. And role model company core values of trust, delighting our customers, Gemba, and Genki.

PRIMARY RESPONSIBILITIES

  • Responsible for receipt and entry of samples in the inventory management system.
  • Performs any combination of sample management tasks, including label, prepare for shipping, transfer to labs, inventory, and disposal.
  • Reviews and verifies sample documents against samples to ensure accuracy and communicate discrepancies. Distributes sample information and documents.
  • Verifies data entry completed by others.
  • Work on LIMS system to support sample management activities.
  • Assists with management of samples in stability studies as needed and directed. Including removal of samples from stability and verification of information.
  • Properly handles, stores, and disposes of hazardous materials according to site procedures.
  • Ensures all work performed strictly adheres to cGMP and FDBC documents.
  • Performs and documents equipment management tasks to maintain QC equipment, which include LN2 freezers, refrigerators, and freezers.
  • Performs document management tasks for sample documents, such as uploading of data reports/data packets into the document management system (Veeva).
  • Performs document management tasks for writing procedures and work instructions.
  • Attends work center team meetings and provides project updates.
  • Perform review of logbook data which includes overall documentation.

SKILLS AND ABILITIES

  • Experience working in laboratory environment.
  • Experience with cGMP and QC Sample Management in the pharmaceutical industry preferred.
  • Knowledge of cell-based bioassay and cell culture is a plus.
  • Experience working in LIMS application.
  • Working in shift schedules. (Morning/Afternoon shifts)
  • Working in a flexible and dynamic environment.

PHYSICAL REQUIREMENTS

Subject to extended periods of sitting and standing, vision to monitor and moderate noise levels. Work is performed in a laboratory environment and includes use of LN2 freezers and lifting/movement of racks of sample boxes.

EDUCATION AND PROFESSIONAL EXPERIENCE

  • High School diploma with 6+ years of experience; or Associates degree with 4+ years of direct laboratory experience; or Bachelor’s degree with 0-3 years of experience.

TRAVEL Not applicable

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