What are the responsibilities and job description for the QC Analyst I , Environmental Monitoring position at Precigen, Inc?
Job Description
Job Description
Precigen is clinical stage biopharmaceutical company advancing an exciting pipeline of novel cell and gene therapy products. We are seeking a hard-working QC Analyst I, Environmental Monitoring (EM) who is serious about their discipline and wants to be a key player in a high-performing team. The QC Analyst, EM position will require performing environmental monitoring sampling and incubation, and analyzing and reporting data according to quality requirements to support GMP manufacturing. Secondary responsibilities include GMP lot release testing.
DUTIES AND RESPONSIBILITIES :
- Perform environmental monitoring duties including sampling of viable surfaces, viable air and non-viable particulates in a GMP Manufacturing Facility.
- Incubate and culture viable EM samples.
- Perform GMP personnel gowning certifications.
- Report results from environmental monitoring and personnel samples and ship for ID testing, when applicable.
- Report and investigate environmental monitoring excursions.
- Track and trend EM data.
- Write and revise QC SOP’s related to environmental monitoring procedures and equipment.
- Perform QC testing of raw materials and schedule testing through contract testing laboratories.
- Perform QC lot release testing including, but not limited to : Endotoxin, Gram Stain.
- Maintain and operate QC laboratory equipment in a cGMP-compliant manner.
- Perform general laboratory maintenance, including ordering and receiving QC materials.
EDUCATION AND EXPERIENCE :
DESIRED KEY COMPETENCIES :
EOE MFDV
