Demo

Quality Control Analyst

Compass Consulting
Valley, CA Full Time
POSTED ON 2/26/2025
AVAILABLE BEFORE 5/23/2025

Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.

Schedule :

Currently 4-10 work hours, with 4 shifts : Sundays- Wed- Days / Swings (7-6 / 1-11) and Wed-Sat - Days / Swings with an overlap on Wednesdays. Seeking candidates who can be OPEN to being flexible in switching their shifts if necessary. Early notice would be provided in the event a switch becomes needed

Responsibilities :

  • Timely facilitation of incoming sample receipt and accessioning flow, decipher batch assignments across all assay types in accordance with agreed upon best practices.
  • Execute microbiological and / or analytical methods to facilitate in-process testing under applicable cGMP guidelines, as well as contribute to the prompt reporting of results to meet the required timetables of internal customers.
  • Perform environmental monitoring sampling and testing of facilities, equipment, and utilities.
  • Evaluate completed assay validity, calculate and summarize results, analyze data per expected or specification ranges. Assist with the compilation and verification of trend analysis reports.
  • Perform and collaborate with co-workers to appropriately share general housekeeping activity assignments, and ensure systems for laboratory maintenance are adequate for creating a consistent state of inspection readiness.
  • Assist with monitoring and the control of laboratory supply and critical reagent inventories.
  • Perform growth promotion of media and microbial identification testing.
  • Qualify as trainer for specified methods, provide training to less experienced staff.
  • Provide on call coverage to support oversight of QC laboratory equipment functionality.
  • Exhibit proactive communication upon occurrence of compliance risks and deviations
  • from laboratory procedures, perform initiation of investigation records within required timeframes.
  • Provide input or assay support to the progression of test method validation, investigations, technical studies, and method transfer protocols.
  • Attend team huddles and department meetings, generate ideas for laboratory infrastructure improvements and method optimization.
  • Perform other responsibilities as deemed necessary.

Qualifications :

  • Experience with quality management systems, current Good Manufacturing Practices, and QC principles.
  • Demonstrated working knowledge with respect to certified functional activities.
  • Good documentation, written and verbal communication skills are essential.
  • Must possess the ability to perform most tasks with minimal supervision.
  • Computer literacy is required, proficiency with Microsoft Word and Excel is essential, experience with Microsoft PowerPoint, Access, or Visio is desired.
  • Must have a quality service attitude and focus, exhibit flexibility and willingness to work additional hours to meet production or laboratory process requirements.
  • Education :

  • Bachelor of Science degree.
  • 0-3 years of relevant laboratory experience; QC specific experience is preferred.
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