SourceRishabh Software Pvt. Ltd
Job Title: Senior QC Micro Analyst Duration: 6 Months+ Location: San Diego, CA 92127 Duties:
- Use experience in all microbiological assay method training to coordinate and perform testing, qualifications, validations and/or other projects that are in addition to typical and/or stability testing.
- To provide expertise to the QC Microbiology Department and to accurately assess the test results for the purpose of supporting both manufacturing and quality assurance in the production, release, and monitoring of established product lines
- Coordinate and perform assays for the QC Microbiology department
- Routine in-process/final product (antigens) bioburden testing for release of product
- Routine testing for release of Seed Stock
- Seedstock Stability testing
- Cleaning and or Process Validation testing
- Product/Method development testing
- Growth Promotion testing
- Microbial Identification testing
- Use experience and method expertise to conduct troubleshooting
- May be assigned to assist with OOS Investigations,
- May be assigned to work independently on Validation and Technical studies
- May be assigned to train staff on test methods
- Comply with Site Environmental Health & Safety (EH&S) requirements
- Must have substantial (three or more) assay experience in one of the main areas listed:
- Microbiological methods such as Microbial Limits Test (bioburden), Sterility, Endotoxin, TOC, Microbial Identification, Contamination testing and Growth Promotion.
- Bacterial and Yeast Seedstocks testing methods such as microscopic examination, viability, contamination, purity and phenotype testing, DNA Plasmid isolation and restriction digest testing.
- Environmental/Utility/facility Monitoring testing such as sampling of and testing of manufacturing water by membrane filtration; viable and non-viable particulate testing of facilities and utilities; viable (surface) monitoring of manufacturing facilities, personnel, and biological hoods; moisture and oil content testing of compressed gases
- Microbiological Method Validation testing such as Bacteriosis and Fungistasis, microbiology or compendial test methods
- Assay trouble shooting experience in their expert area
- Proficient in MS Word, MS PowerPoint, and MS Excel software
- Must be familiar with GMP's and Quality System Regulations (QS Regs)
- Must have good time management, effectively prioritizing tasks for completion
- Individual must work in an ethical manner and ensure employees follow client ethics and compliance guidelines.
- At least 3 years' experience in a regulated GMP testing laboratory
- Bachelor's degree in a Scientific Field with at least 3 years of relevant industry experience.
- Candidates without a degree will be considered if they have at least 7 yrs. relevant industry experience.