QC Microbiologist II jobs in United States
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Curia · 1 day ago

QC Microbiologist II

Curia is a company focused on quality control in the microbiology field, seeking a Quality Control Microbiologist II. The role involves performing quality activities in support of product production and releases, including testing, trending, and reporting results to ensure compliance with regulatory requirements.

BiotechnologyHealth CareManufacturing
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H1B Sponsor Likelynote

Responsibilities

Lead and/or support quality event investigations for out-of-specification (OOS), out-of-trend (OOT) or nonconformance events
Perform environmental monitoring of clean rooms (under ISO and EU specifications)
Perform and review QC testing (Endotoxin, Bioburden, TOC, Conductivity, Growth Promotion Assay, etc.) for manufacturing, raw materials, in-process materials, intermediates and final product
Demonstrate technical proficiency in test procedures and ensure QC activities are carried out using applicable regulatory requirements (FDA, USP, ICH etc.)
Participate in audits, client investigations, and project-related activities
Lead and/or support activities associated with Change Control, CAPAs, client audit response, work orders, etc
Receive and process samples to meet production/client timelines
Read, trend and report environmental, personnel, in-process, raw material, finish product and water bioburden testing results
Prepare and send out samples for microbiological identification
Ensure QC sample testing (e.g. in-process, lot release, stability, EM, water) and data approval deadlines are met
Work closely and collaborate in a team environment with QC Analytical and Quality Assurance, Manufacturing, Technical Services, Materials Receiving, and Research and Development
Ensure the successful implementation and execution of new QC methods/procedures and equipment
Perform trending of QC data and present information to Management
Perform general laboratory housekeeping
Author, review, and approve microbiology test results and analytical methods as needed
Ensure QC sample testing (e.g. in-process, lot release, stability, EM, water) and data approval deadlines are met
Support Manufacturing with client-specific testing requirements
Inspection of media fills

Qualification

MicrobiologyGMP complianceEnvironmental monitoringFDA regulationsMicrosoft Office SuiteOrganizational skillsTime managementCommunication skills

Required

Bachelor's Degree in Microbiology or related field
Minimum 3-5 years' industry experience in a GMP sterile finish or pharmaceutical cleanroom environment
Strong organizational skills and the ability to prioritize/multitask
Proficient in Microsoft Office Suite (excel)
Attention to details and following GMP methods and instructions
Strong time management and organizational skills with the ability to multi-task and manage multiple projects independently
Excellent verbal and written communication skills, including the ability to effectively present information and respond to questions from groups of managers, clients, and customers
Ability to write reports, business correspondence, and procedures
Ability to define problems, collect data, establish facts, and draw valid conclusions
Must pass a background check
Must pass a drug screen
May be required to pass Occupational Health Screening

Preferred

Proficient in the validation/qualification of lab microbiological techniques preferred
Knowledgeable in FDA cGMPs (21 CFR 211); ISO 9001, 13485 and 17025 a plus
Knowledgeable in USP

Benefits

Generous benefit options (eligible first day of employment)
Paid training, vacation and holidays (vacation accrual begins on first day of employment)
Career advancement opportunities
Education reimbursement
401K program with matching contributions
Learning platform
And more!

Company

Curia is a biotechnology company that offers discovery biology, synthetic, medicinal chemistry, and small-scale manufacturing services.

H1B Sponsorship

Curia has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (34)
2024 (17)
2023 (8)

Funding

Current Stage
Late Stage
Total Funding
unknown
2025-03-07Debt Financing
2017-08-31Private Equity

Leadership Team

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Steve Lavezoli
Vice President, Biologics Division
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Company data provided by crunchbase