Quality Control Analyst, GMP Product Testing
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Job Description
Are you someone who takes initiative, thrives in dynamic environments, and is driven to make a meaningful impact? At Direct Biologics, we’re redefining regenerative medicine, and we’re looking for a proactive, results-driven Quality Control Analyst who’s ready to own their role and grow with us.
About Us
Direct Biologics is a fast-scaling biotechnology company pioneering cutting-edge regenerative therapies. Our mission as a pioneering leader and cGMP manufacturer of regenerative biologic products is to deliver cutting-edge clinical and scientific solutions through meticulous research efforts driven by science and innovation.
We move fast, think boldly, and empower our team to do the same.
Why This Role Matters
This isn’t a plug-and-play role. As a Quality Control Analyst, you’ll be a key player ensuring the integrity, safety, and performance of our advanced therapeutic products. You’ll be entrusted with high-impact responsibilities that shape how our life-saving therapies reach the market.
If you're a self-starter who craves ownership and thrives on solving complex problems, you’ll fit right in.
What You’ll Do
- Lead hands-on testing of drug substances and products using advanced analytical tools: ELISA, qPCR, immunostaining, RNA/protein quantification, and more.
- Collaborate cross-functionally with AD/PD, Manufacturing, Regulatory, and QA teams—your insights will directly shape product evolution.
- Author and revise SOPs and test records with precision and ownership of GDP standards.
- Drive GMP method transfer and implement improvements with a “how can we do this better?” mindset.
- Execute stability and characterization studies to ensure our products meet the highest standards of identity, potency, and purity.
- Maintain lab readiness and equipment qualification proactively—no waiting for someone else to flag issues.
- Keep inventory sharp and lab operations running smoothly by anticipating supply needs.
- Generate clear, concise reports that provide actionable insights, not just data.
You’ll Excel Here If You:
- Enjoy working autonomously and taking initiative without waiting for directions.
- Have strong technical chops in analytical techniques and hands-on lab experience.
- Know how to manage time in a fast-paced, priority-shifting environment.
- Think critically, document precisely, and communicate clearly.
- Are driven by impact, not just process—your work will help bring life-changing therapies to patients.
Join Us
At Direct Biologics, we believe in empowering talent and fostering a culture of ownership, agility, and growth while focusing on our core Values; safety, quality, and innovation. If you’re ready to step into a role where your ideas, initiative, and drive truly matter—we want to hear from you.
Requirements
- Education: BS/MS in Biotechnology, Molecular Biology, Biochemistry, Biomedical Engineering, or a related field.
- Experience: 1–2+ years in GMP-regulated biotech/pharma settings.
- Familiarity with GMP, GDP, Quality Systems (OOS, deviations, CAPAs), and analytical testing protocols.
- Proficiency in modern laboratory instrumentation and documentation.
Benefits
- Profit Interest Units (PIUs) incentives
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan (401k, IRA)
- Paid Time Off (Vacation, Sick & Public Holidays)