- High energy QC Bioburden and LAL Analyst, who is ready to help shape the future by confronting new challenges, embracing new experiences, and taking on increasing responsibilities within the QC Bioburden and Endotoxin lab.
- Assist QC Manager and Lead on the day-to-day tasks
- Perform routine and non-routine microbiological and endotoxin data review of commercial and Bio-Development products, including raw materials, water, in-process
- Review of data recording, reporting, and releasing in the following systems: Sapphire LIMS, MODA, SAP, WinKQCL Software, Dev@com, REES, BAS
- Generate Memorandums for Data Verifications, Deviations
- Generate validation protocols and reports for new products for both (LAL testing)
- Qualifications of new Reagents and Equipment
- Method validation periodic review
- Preparation, verification, and review of monthly and yearly Bioburden reports
- Assist in investigation of Deviations and CAPAs
- Oversee Preventative Maintenance of lab equipment
- Assisted in Method Verifications (Endotoxin), AMA's, IOPQ's
- Support other laboratories/production for release results or reports
- Archive paperwork such as laboratory records, Certificates of Calibrations
- Daily supervision of laboratory. Rush samples, coordinate testing and validation.
- Efficient and Detail orientated
- Ability to generate validation protocols, reports
- Ability to work independently and multi-task
- Strong computer skills with Microsoft Office with beginner level proficiency with Word, Excel and PowerPoint.
- Demonstrated potential for technical proficiency, scientific creativity, and collaboration with others and independent thought.
- Use computers for various applications, such as data base management or word processing
- Experience with Endotoxin troubleshooting preferred
- BS and 1-3 years experience
Job Type: Contract
Salary: $25.00 per hour
Schedule:
- 8 hour shift
- Monday to Friday
Work Location: One location
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