Job Title: Analyst, QC Critical Reagents

Duration: 12 months, 40 hrs / week

Location: Novato, CA

SUMMARY

The QC Critical Reagents Analyst is responsible for maintaining the Critical Reagents program for commercial products in the global network, including but not limited to reagent preparation, maintaining material inventory, generating technical documentation, and supplying materials to the global testing network. Materials in the Critical Reagents program include qualified reagents, reference standards, custom reagents, analytical cell banks, and other important materials that require dedicated oversight. The individual prepares trend graphs and analyses for Critical Reagents to support routine requalification activities, regulatory responses, and investigational activities.

RESPONSIBILITIES

1. Responsible for critical reagent acquisition, preparation, and aliquoting.
2. Coordinates qualification testing with laboratory personnel.
3. Coordinates and executes critical reagent distributions for the global testing network.
4. Utilizes LIMS to document acquisition and preparation of critical reagents, to monitor testing status of critical reagents, and to extract data for trend analyses.
5. Generates and maintains critical reagent trending graphs to monitor material stability, assay performance and suitability of qualified ranges, and to support technical documentation.
6. Maintains critical reagent inventory and participates in forecasting of critical reagents supply demands.
7. Provides input to and/or authors critical reagent technical documentation, including protocols and reports for qualification, requalification, expiry extension, qualified ranges, etc.
8. Perform data verification of technical documentation.
9. Participate in the generation of new ideas to create efficiencies and improve processes; willingly supports new ideas and process enhancements. Engages in continuous improvement.
10. Attend team huddles, department meetings and standard work meetings as required.
11. Other duties as assigned.

Required Skills:

1. 0-3 years of relevant laboratory experience.
2. Excellent documentation, written and verbal communication skills.
3. Computer literacy is required, including proficiency with Microsoft Word and Excel.
4. Must have a quality service attitude and focus, exhibit flexibility and willingness to work additional hours to meet production or process requirements.

Desired Skills:

1. Experience with quality management systems, current Good Manufacturing Practices, and detailed knowledge of QC principles and compliance requirements.
2. Works with ambiguity and complexity to continuously modify options and solutions.
3. Experience with Microsoft PowerPoint, Teams, or Visio is desired.
4. Familiar with relevant regulations, including 21CFR, USP, EP, and ICH requirements.