Senior Analyst, Quality Control (EM &Micro) 2nd Shift
Forge BiologicsColumbus, Ohio, United States · Posted 2 days agoDescription
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.
Position Overview:
Senior Analyst, Quality Control (EM &Micro) will serve as Subject Matter Expert (SME) for EM testing and Microbiology Lab testing and takes ownership of the different testing, collaborating of quality initiatives and in providing technical guidance to the junior staff. This role provides opportunities to utilize experience and implement new technologies in QC Microbiology.
Responsibilities:
- Serve as SME for EM and Microbiology testing in trouble shooting, enhancement to micro methods and EM sample management.
- Take responsibility for establishing testing timelines, execution, and monitoring the test results for Growth promotion, Bioburden, Microbial ID, Bubble point, Endotoxin, Sterility, pH, Osmolality, Biological Indicators, etc.
- Assist with writing and implementing SOP’s, work instructions and protocols according to cGMP and Forge guidelines.
- Oversee scheduling, tracking and release of QC Buffer testing (pH, Conductivity, Bioburden Endotoxin, and Osmolality).
- Perform / Review of Laboratory investigations, Deviations, Change controls, CAPAs etc. in a timely manner.
- Oversee timely entry of various testing results into databases and assist timely closure of EM trending reports.
- Submit purchase orders for equipment and materials-Inventory Management
- Assist with APS, hold time studies, BI studies, BB and Sterility validations and other validations activities.
- Work collaboratively with cross functional teams to improve quality, increase efficiency and turnaround of Micro/EM testing results.
- Perform training and technical guidance on laboratory methods and instrumentation to other Junior Analysts.
- Support regulatory and client inspections and support QC EM/Micro in internal audits.
- Perform other duties as assigned
Qualifications:
- Bachelor’s degree in microbiology, Biology or related scientific field required.
- Minimum of 4 years of experience in a GMP-regulated QC or EM environment including Microbiology Laboratory.
- Demonstrated proficiency in microbiology laboratory techniques such as Bioburden by membrane filtration/Milliflex, Endotoxin analysis, Sterility testing, Growth Promotion testing, biological indicators, Chemical Indicators, Filter integrity testing, Buffer Testing etc.
- Demonstrate proficiency and understanding of Environmental Monitoring, Clean room sampling with air samplers (viable and non-viable), surface sampling.
- Experience in understanding/ implementing RMMs and other new methodologies ( eg; Sterility testing)
- Demonstrated experience in drafting EMPQ protocols, risk assessments, and final EMPQ reports, etc.
- Demonstrated experience in performing Deviations and Lab investigations, Change controls, CAPAs and new document/SOP creation using Veeva Vault/Trackwise, and other software (JMP, LIMS, NetSuites etc.)
- Previous experience or demonstrated skills to lead/mentor a group of QC Analysts.
Preferred Skills:
- Experience leading EMPQ and other EM projects.
- Experience in supervising QC Microbiology lab testing.
- Experienced in Interactions with regulatory inspections or audits.
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