QC Microbiologist I jobs in United States
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Anika · 1 month ago

QC Microbiologist I

Anika is a company focused on microbiological testing and validation within the pharmaceutical industry. They are seeking a QC Microbiologist I responsible for performing microbiological testing of production materials and ensuring compliance with GMP standards.

BiotechnologyHealth CareManufacturingTherapeutics
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H1B Sponsor Likelynote

Responsibilities

Perform bioburden, sterility and endotoxin testing of raw materials, in-process samples, bulk and finished products and stability samples
Perform company’s purified water and DI water bioburden, endotoxin and TOC testing as per USP requirements
Complete all required documentation according to SOP
Verify work of technicians and assist in training
Review environmental condition of classified areas, maintain database for environmental results of clean room environment and summarize data for annual environmental report
Provide training on environmental compliance issues
Development and validation of new or improved microbiological methods
Writing and/or approving validation protocols, coordinating and/or performing validation and writing and/or approving validation reports
Establishing databases for microbiological and validation data
Performs Internal Audits as scheduled
Other duties and projects as assigned

Qualification

Microbiological testingGMP complianceValidation protocolsEnvironmental monitoringPharmaceutical industry experienceMicrosoft Office SuiteCommunication

Required

Requires BS in microbiology, biology or related science or equivalent experience
1+ years experience in pharmaceutical industry with microbiological testing such as sterility/bioburden, new product validation, LAL testing and validation, microbial identification, gram staining, purified water testing as per USP (membrane filtration, endotoxin and TOC), bacteriostasis and growth promotion assay
Experience with GMP, GLP, and FDA regulations and ISO requirements
Experience in environmental monitoring of clean room, aseptic media fill evaluation
Excellent verbal and written communication skills
Proven ability to meet deadlines for testing and reporting
Proficient in the use of Microsoft Office Suite including PowerPoint

Company

Anika

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Anika is a global joint preservation company that creates and delivers meaningful advancements in early intervention orthopedic care.

H1B Sponsorship

Anika 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 (3)
2024 (3)
2023 (1)
2022 (1)
2021 (4)

Funding

Current Stage
Public Company
Total Funding
unknown
Key Investors
Caligan Partners
2024-03-07Post Ipo Equity
1993-05-14IPO

Leadership Team

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Cheryl Blanchard
President and CEO
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Company data provided by crunchbase