Overview
On Site
$28
Contract - W2
Contract - 6 Month(s)
Skills
QSR
cGMP
FDA
CTP/SOPs
Job Details
DivIHN (pronounced divine ) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.
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For further inquiries regarding the following opportunity, please contact one of our Talent Specialists.
Meghna at
Hema at
Meghna at
Hema at
Job Title: QC Analyst I Microbiology
Location: Hayward, CA
Duration: 6 Months
Location: Hayward, CA
Duration: 6 Months
Hours: 8am-4:30pm (flexible)
Description:
Summary:
- Conduct environmental monitoring of ISO 5, 7, 8, and 9 cleanrooms at Client manufacturing facilities, along with Water collection.
- Support Microbiology analysis, such as raw materials, in-process, and finished goods product samples at the client's manufacturing facility.
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- BaxLIMS
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.
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- BaxLIMS
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.
Qualifications
- 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
- B.S. degree in Microbiology, Biology
Experience
- Minimum 1-2-year experience in Pharmaceutical/Medical Device industry preferred.
About us:
DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.