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Minaris Advanced Therapies · 1 day ago

QC Micro - QC Microbiology Analyst I

Allendale, NJ

Contract

Onsite

New Grad, Entry Level

0+ years exp

Minaris Advanced Therapies is a global leader in cell and gene therapy development, manufacturing, and testing, dedicated to creating hope for patients around the world. The Quality Control Microbiology Analyst I serves as a support role to clinical and/or commercial production, performing environmental monitoring activities and ensuring compliance with quality standards.

BiotechnologyHealth CareManufacturing

H1B Sponsor Likely

Responsibilities

Environmental monitoring in controlled rooms: perform Non-viable and viable monitoring, Active viable air, Personnel monitoring, Surface sampling, Passive air monitoring, Equipment EM monitoring. Perform plate reads and incubations

Environmental Monitoring data review and EM trending

Ensure equipment is properly maintained/calibrated and monitored in Vaisala system

Initiate quality events in Veeva and triage events with outside departments

Assist with routine laboratory testing

Inventory Management of lab materials and instruments

Shipping of test samples and equipment to contract laboratories for testing

Maintain laboratory audit readiness/Good Laboratory housekeeping practices

Any additional request, per management needs

Complete all documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)

Regular and reliable attendance on a full-time basis

Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices

Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture

Qualification

Environmental monitoringQuality systems knowledgeTechnical writingMicrosoft OfficeMODA/LIMSDetail orientedTeamworkCommunication skillsFlexibility

Required

BA/BS in a science or relevant field required or equivalent experience

Minimum 0-2 years of experience or equivalent experience

Knowledge of quality systems and ability to interpret Quality standards for implementation and review

Strong written and oral communication skills

Technical writing skills

Technical training experience

Must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities

Regular and reliable attendance on a full-time basis

Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture

Preferred

Experience in Environmental monitoring or within the biopharmaceutical industry experience preferred

Proficient with computer software such as Microsoft Office, MODA/LIMS

Must be flexible with Production schedule which may require coming in early or working later

Benefits

Medical insurance

Vision insurance

Dental insurance

401(k)

Paid time off

Tuition assistance

And more

Company

Minaris Advanced Therapies

Minaris Advanced Therapies is a global cell and gene therapy (CGT) CDMO and a multimodality biosafety testing provider.

Founded in 1999

Allendale, New Jersey, USA

1001-5000 employees

https://www.rm.minaris.com

H1B Sponsorship

Minaris Advanced Therapies 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

2024 (1)

2022 (1)

2021 (1)