SPECTRAFORCE
Position Title:
Quality Control Analyst (Microbiology) Work Location:
Hayward, CA 94545 / USA Assignment Duration:
6 months Work Schedule:
8am-4:30pm (flexible) Work Arrangement:
Onsite position Position Summary:
Conduct environmental monitoring of ISO 5, 7, 8, and 9 cleanrooms at manufacturing facilities along with Water collection. Support Microbiology analysis such as raw materials, in-process and finished goods products samples at manufacturing facility. Key Responsibilities
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 – LIMS. Complete 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. Qualification & Experience
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-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. Education and/or Experience
B.S. degree in Microbiology, Biology; minimum 1-2-year experience in Pharmaceutical/Medical Device industry preferred.
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Quality Control Analyst (Microbiology) Work Location:
Hayward, CA 94545 / USA Assignment Duration:
6 months Work Schedule:
8am-4:30pm (flexible) Work Arrangement:
Onsite position Position Summary:
Conduct environmental monitoring of ISO 5, 7, 8, and 9 cleanrooms at manufacturing facilities along with Water collection. Support Microbiology analysis such as raw materials, in-process and finished goods products samples at manufacturing facility. Key Responsibilities
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 – LIMS. Complete 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. Qualification & Experience
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-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. Education and/or Experience
B.S. degree in Microbiology, Biology; minimum 1-2-year experience in Pharmaceutical/Medical Device industry preferred.
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