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
Skills:
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
Occupational Demands: May occasionally lift, carry, push, pull or otherwise manipulate objects up to 25 pounds in weight, and/or lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight frequently or continuously.
NOTE: Notification of Hep B Vaccine required.
Education:
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.
Skills and Experience: Required Skills: Bacterial Bioburden Contamination DNA GMP
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
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