QC RM Analyst II

Forge Your Future with Us:
At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from ideas into reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities — all united by one goal: improving lives. If you’re driven by purpose and excited to make a tangible impact, this is where your journey begins.

Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio. Here, you won’t just watch innovation happen — you’ll be part of it. Whether you’re scaling AAV manufacturing, collaborating on cutting‑edge therapies, or supporting complex technical projects, you’ll play a key role in bringing hope to patients with genetic diseases. What sets Forge apart is our culture of H.O.P.E. We are hardworking , showing up each day with determination and grit.

We are open , creating a space where ideas flow freely, and every voice is valued. We are purpose‑driven , with every task directly tied to changing lives. And we are engaged , energized by the challenges we face and the milestones we achieve together. At Forge, your growth matters. We’re committed to helping you expand your skills, take on new challenges, and develop your career through mentorship, hands‑on learning, and opportunities for advancement.

Our people are our greatest investment, and we’re proud to see team members grow with us. If you’re ready to use your talent to help deliver hope to patients around the world, join us — and be part of something bigger than yourself.

We are currently seeking an Analyst I I , Quality Control (Raw Materials) to join the Forge Biologics team. In this role, you will be responsible for conducting testing and evaluation of raw materials used in AAV vector production. Your work will involve material sampling and executing various analytical tests per the processes defined within SOP documents in a cGMP compliant manner.

Additionally, you will be responsible for performing comparisons between measured results and expected criteria and communicating those comparisons in a timely and thorough way. Your contribution will be essential in maintaining the integrity and safety of our gene therapy products.

• Inspectallmaterialsthatarriveatthefacilityforintegrityandquality.
• Sample materials in a clean room environment
• Communicatebetweendepartmentstoensureall operationshaveallrequiredinspectedmaterials.
• Performroutinetestingandanalysisofrawmaterialsusingestablishedprotocolsandanalyticalmethods.
• Conduct arangeoftests,including butnotlimitedtoidentity,purity,potency, and microbial contamination,on incoming raw materials.
• Accuratelydocumenttestresults, observations,andproceduresinaccordancewith
  
  Good Documentation Practices  (GDP).
• Collaboratewiththeprocurementteamtoensuretimelyreceiptandtestingofrawmaterials.
• Escalateanynon-conformanceordeviationstoappropriatechannelsforinvestigationandresolution.
• Assistinthedevelopmentandoptimizationofnewtestingmethodsandprocedures.
• Contributestothemaintenance,calibration,andqualificationoflaboratoryequipment.
• Supports the onboarding and training of team membersinroutine tasks and established procedures.
• Adhereto Standard Operating Procedures (SOPs),cGMPguidelines,andregulatoryrequirements.

• Associate’s or Bachelor’sDegreein
  
  Biology,Biochemistry,Chemistryorarelateddiscipline.
• Familiaritywithbasiclaboratorytechniquesandanalyticalmethods.
• Ability to lift 50lbs

• Priorexperienceinalaboratoryorqualitycontrolenvironment.
• Sampling in acleanroom environment
• UnderstandingofcGMPandregulatoryguidelines.

• Attentiontodetail,accuracy,andtheabilitytofollowprotocols.
• Strongorganizationalanddocumentationskills.
• Effectivecommunicationandabilitytoworkwithinateam.
• Willingnesstolearnandadapttonewtechniquesandtechnologies.

This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job.…