Analyst, QC I
46 Galli Road Novato, CA 94949 US
Job Description
- EXCEL
- DOCUMENTATION
- LABORATORY
- MICROSOFT WORD
- ANALYTICAL ASSAYS
- HOUSEKEEPING
- MICROBIOLOGICAL
- MICROSOFT POWERPOINT
- CGMP
- MAINTENANCE
- EXCELLENT WRITTEN AND VERBAL COMMUNICATION SKILLS
- SAMPLING
- METHOD VALIDATION
- PROCESS TESTING
- ?
RESPONSIBILITIES
1. Timely facilitation of incoming sample receipt and accessioning flow, decipher batch
assignments across all assay types in accordance with agreed upon best practices.
2. 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.
3. Perform environmental monitoring sampling and testing of facilities, equipment, and
utilities.
4. 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.
5. 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.
6. Assist with monitoring and the control of laboratory supply and critical reagent
inventories.
7. Perform growth promotion of media and microbial identification testing.
8. Qualify as trainer for specified methods, provide training to less experienced staff.
9. Provide on call coverage to support oversight of QC laboratory equipment functionality.
10. Exhibit proactive communication upon occurrence of compliance risks and deviations
from laboratory procedures, perform initiation of investigation records within required
timeframes.
11. Provide input or assay support to the progression of test method validation,
investigations, technical studies, and method transfer protocols.
12. Attend team huddles and department meetings, generate ideas for laboratory
infrastructure improvements and method optimization.
13. Perform other responsibilities as deemed necessary.
EDUCATION
1. Bachelor of Science degree.
2. 0-3 years of relevant laboratory experience; QC specific experience is preferred.
QUALIFICATIONS
1. Experience with quality management systems, current Good Manufacturing Practices,
and QC principles.
2. Demonstrated working knowledge with respect to certified functional activities.
3. Good documentation, written and verbal communication skills are essential.
4. Must possess the ability to perform most tasks with minimal supervision.
5. Computer literacy is required, proficiency with Microsoft Word and Excel is essential,
experience with Microsoft PowerPoint, Access, or Visio is desired.
6. Must have a quality service attitude and focus, exhibit flexibility and willingness to work
additional hours to meet production or laboratory process requirements.
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