Senior Analyst, Quality Control (EM &Micro) 2nd Shift
About The Position
Forge Biologics is seeking a Senior Analyst, Quality Control (EM &Micro) to serve as a Subject Matter Expert (SME) for Environmental Monitoring (EM) testing and Microbiology Laboratory testing. This role involves taking ownership of various testing processes, collaborating on quality initiatives, and providing technical guidance to junior staff. The position offers opportunities to leverage experience and implement new technologies within the QC Microbiology department. The company operates out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio, focusing on bringing life-changing gene therapies from ideas into reality. Forge Biologics fosters a culture of H.O.P.E. (Hardworking, Open, Purpose-driven, Engaged) and is committed to employee growth through mentorship, hands-on learning, and advancement opportunities.
Requirements
- 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.
Nice To Haves
- Experience leading EMPQ and other EM projects.
- Experience in supervising QC Microbiology lab testing.
- Experienced in Interactions with regulatory inspections or audits.
- Expertise risk assessment tools and quality systems.
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
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
- 12 weeks of fully paid parental leave
- Annual bonus opportunities for all full-time team members.
- 401(k) with company match
- 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
- A fully stocked kitchen with free snacks and beverages
- Ongoing professional development resources, training, and mentorship programs
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What This Job Offers
Job Type
Full-time
Career Level
Senior
