Quality Control Analyst I jobs in United States
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Forge Biologics · 12 hours ago

Quality Control Analyst I

Forge Biologics is dedicated to enabling access to life-changing gene therapies. The Quality Control Analyst I will conduct microbiological testing and environmental monitoring in a GMP facility, ensuring compliance with regulatory standards while supporting the implementation of new technologies.

BiotechnologyHealth CareMedicalTherapeutics
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Growth Opportunities
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H1B Sponsor Likelynote

Responsibilities

Conduct various microbiological tests in a laboratory setting, including Gram staining, Endotoxin analysis, Bioburden determination, Osmolality measurements, and pH testing
Execute environmental monitoring activities by collecting air and surface samples within designated cleanroom areas to ensure compliance with regulatory standards
Assist in analyzing Environmental Monitoring data trends using software such as JMP and LIMS to identify potential areas for improvement or compliance issues
Participate in thorough investigations to determine the root cause of OOS results and contribute to the implementation of corrective and preventive actions in a timely manner
Develop and implement work plans to meet production and scheduling requirements from both internal and external clients, ensuring timely completion of tasks
Prepare microbiological equipment, samples, environmental monitoring data forms, and labels for testing, ensuring accuracy and compliance with protocols
Collaborate in Media Fill, Process Simulation, and Smoke Studies to evaluate and validate manufacturing processes and equipment performance

Qualification

Microbiological testingEnvironmental monitoringGxP environment experienceAseptic techniqueData analysis JMPData analysis LIMSOrganizational skillsCommunication skillsProblem-solvingTeam collaboration

Required

Bachelor's Degree in Microbiology, Biology or related scientific field (or equivalent work experience)
Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems
Excellent organizational skills and the ability to multitask in a fast-paced environment while adhering to strict timelines
Good interpersonal and communication skills, both written and verbal, to effectively collaborate with team members and stakeholders
Ability to adapt to changing priorities and work independently as well as part of a team
Flexibility to work in shifts, including weekends and holidays, as required by manufacturing schedules

Preferred

Knowledge of aseptic technique or behavior
Experience in a GxP environment or other regulated industry
Prior experience performing microbial testing including but not limited to: Gram-stain, Endotoxin, Bioburden, Osmolality, pH, etc

Benefits

Health, dental and vision insurance start your first day – with 90% of premiums covered for you and your family.
A competitive paid time off plan – because rest fuels innovation.
12 weeks of fully paid parental leave so you can focus on family when it matters most.
Annual bonus opportunities for all full-time team members.
401(k) with company match to help you plan for the future.
Special employee discounts, including childcare and dependent care savings.
Onsite fitness facility at The Hearth.
Mental health counseling and financial planning services through our Employee Assistance Program.
Employer-paid short and long-term disability coverage to protect your peace of mind.
A fully stocked kitchen with free snacks and beverages – we keep you energized and ready for what’s next.
Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.

Company

Forge Biologics

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Forge Biologics is a gene therapy development engine, enabling access to life changing gene therapy programs.

H1B Sponsorship

Forge Biologics 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 (7)
2024 (4)
2023 (2)
2022 (1)

Funding

Current Stage
Growth Stage
Total Funding
$330M
Key Investors
State of OhioMidCap FinancialRA Capital Management
2023-11-13Acquired
2022-09-12Series C· $90M
2022-01-10Grant

Leadership Team

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Timothy J. Miller, Ph.D. (he/him)
Cofounder, President & CEO
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Erandi De Silva, PhD
Co-founder, Senior Vice President of Product Development
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Company data provided by crunchbase