Jobs via Dice
Overview
Microbiology Quality Control Analyst at Stefanini Group, Hayward, CA (Onsite).
Work hours: Monday–Friday, 40 hours per week. Shift: 1st Shift – 8:00 AM – 4:30 PM (Flexible).
Responsibilities
Conduct environmental monitoring of ISO 5–9 cleanrooms and collect water samples at client manufacturing facilities.
Perform microbiological analysis on raw materials, in‑process and finished goods samples, and samples from environmental monitoring programs.
Support Endotoxin, Bioburden, growth promotion, and other required tests.
Read microbial plates, interpret results, and enter QC data into Sample Manager (LIMS).
Complete all testing, including special project / protocol testing, in a timely and appropriate manner.
Maintain equipment maintenance, calibrations, and ensure compliance with SOPs, FDA, GLP, QSR, and cGMP regulations.
Perform or support all NCRs, CAPAs, and LIRs, and serve as point of contact for updates with other departments.
Participate in cross‑functional teams to increase production efficiency, solve problems, generate cost savings, and improve quality.
Perform laboratory and manufacturing audits and update plant/lab SOPs as required.
Ensure environmental monitoring area is always maintained in a GMP state while following EHS and 6S guidelines.
Execute other duties as assigned or as business needs require.
Work and communicate professionally with others inside and outside the company. Weekend work may be required to meet production timeline schedules.
Qualifications
B.S. degree in Microbiology, Biology, or related field.
Minimum 1–2 years experience in the pharmaceutical / medical device industry preferred.
Ability to handle multiple tasks concurrently and complete tasks in a timely manner.
Effective organizational skills to plan and resolve technical problems.
Knowledge of assays/equipment in functional area and proficiency with laboratory equipment.
Computer literacy and competency with Microsoft Office (Word, Excel).
Detail‑oriented, conscientious, responsible, and strong verbal and written communication skills.
Some knowledge of applicable CTP/SOPs, EHS requirements, FDA regulations, CGMP/GDPs.
Ability to learn new computer systems and programs in a timely manner.
Salary Listed salary ranges may vary based on experience, qualifications, and local market.
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Work hours: Monday–Friday, 40 hours per week. Shift: 1st Shift – 8:00 AM – 4:30 PM (Flexible).
Responsibilities
Conduct environmental monitoring of ISO 5–9 cleanrooms and collect water samples at client manufacturing facilities.
Perform microbiological analysis on raw materials, in‑process and finished goods samples, and samples from environmental monitoring programs.
Support Endotoxin, Bioburden, growth promotion, and other required tests.
Read microbial plates, interpret results, and enter QC data into Sample Manager (LIMS).
Complete all testing, including special project / protocol testing, in a timely and appropriate manner.
Maintain equipment maintenance, calibrations, and ensure compliance with SOPs, FDA, GLP, QSR, and cGMP regulations.
Perform or support all NCRs, CAPAs, and LIRs, and serve as point of contact for updates with other departments.
Participate in cross‑functional teams to increase production efficiency, solve problems, generate cost savings, and improve quality.
Perform laboratory and manufacturing audits and update plant/lab SOPs as required.
Ensure environmental monitoring area is always maintained in a GMP state while following EHS and 6S guidelines.
Execute other duties as assigned or as business needs require.
Work and communicate professionally with others inside and outside the company. Weekend work may be required to meet production timeline schedules.
Qualifications
B.S. degree in Microbiology, Biology, or related field.
Minimum 1–2 years experience in the pharmaceutical / medical device industry preferred.
Ability to handle multiple tasks concurrently and complete tasks in a timely manner.
Effective organizational skills to plan and resolve technical problems.
Knowledge of assays/equipment in functional area and proficiency with laboratory equipment.
Computer literacy and competency with Microsoft Office (Word, Excel).
Detail‑oriented, conscientious, responsible, and strong verbal and written communication skills.
Some knowledge of applicable CTP/SOPs, EHS requirements, FDA regulations, CGMP/GDPs.
Ability to learn new computer systems and programs in a timely manner.
Salary Listed salary ranges may vary based on experience, qualifications, and local market.
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