Microbiology Quality Control Analyst

Stefanini Group is hiring!

Stefanini is looking for Microbiology Quality Control Analyst in Hayward, CA (Onsite)

For quick Apply, please reach out to Sangeeta Dasadhikary - call: /email:

Work Hours: M-F (40 hours)

Work Location: Hayward, CA (Onsite)

Shift: 1st Shift - 8:00 AM - 4:30 PM (Flexible)



Conduct environmental monitoring of ISO 5, 7, 8, and 9 cleanrooms at clients manufacturing facilities along with Water collection. Support Microbiology analysis such as raw materials, in-process and finished goods products samples at manufacturing facility.

Conduct Microbiological analysis on raw materials, initial, in-process and final products, and samples collected from the environmental monitoring programs at manufacturing facility.Testing as required supporting Endotoxin testing, Bioburden analysis, growth promotion, Will be required to read microbial plates and interpret test results.QC Data entry in Sample manager- LIMSComplete all testing, including special project / protocol testing in a timely and appropriate manner.Perform equipment maintenance and calibrations as required.Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.Perform/or support all NCRs, CAPAs, and LIRs and be the point of contact for other departments for updates.Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings, and improve quality.Perform laboratory and manufacturing audits as required. Audit and update, as required, plant/lab SOPs.Ensure Environmental Monitoring area is always maintained in a GMP state while following all EHS and 6S guidelines.Flexibility in performing other duties, as assigned, or as business needs require.Works and communicates effectively and professionally with others inside and outside the company.Weekend work may be required as needed to meet production timeline schedules.

B.S. degree in Microbiology, Biology; minimum 1-2-year experience in Pharmaceutical/Medical Device industry preferred.Ability to handle multiple tasks concurrently and complete tasks in a timely manner.Effective organizational skills and ability to plan and suggest resolutions to technical problems.Demonstrates some knowledge of assays/equipment in functional area. Computers literate and competent with a general knowledge of word processing and spreadsheets (such as Microsoft Office).Proficient use of laboratory equipment and tools. Must be detail[1]oriented, conscientious, and responsible. Must have effective verbal and written communication skills. Some knowledge of applicable CTP/SOPs, EHS requirements, FDA Regulations application of CGMP/GDPs.Must be able to learn about new computer systems and programs in a timely manner. Must be able to learn new computer systems and programs in a timely manner.



Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives.



Stefanini takes pride in hiring top talent and developing relationships with our future employees. Our talent acquisition teams will never make an offer of employment without having a phone conversation with you. Those face-to-face conversations will involve a description of the job for which you have applied. We also speak with you about the process including interviews and job offers.



About Stefanini Group

The Stefanini Group is a global provider of offshore, onshore, and near shore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas, Europe, Africa, and Asia, and more than four hundred clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting company with a global presence. We are CMM Level 5 company.



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