Senior Analyst, Quality Control (EM &Micro) 2nd Shift

About the role

Forge Biologics is a forward-thinking organization dedicated to transforming bold ideas into life-changing gene therapies. Our mission is to ensure these therapies are accessible and to collaborate with scientists, physicians, biotech, and pharmaceutical innovators, as well as patient communities, to improve lives.

Responsibilities

• Serve as Subject Matter Expert (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.
• Avoid 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.
• Avoid 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.
• Avoid Support regulatory and client inspections and support QC EM/Micro in internal audits.

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).
• Demonstrate experience in drafting EMPQ protocols, risk assessments, and final EMPQ reports, etc.
• Demonstrate 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.
• Expertise risk assessment tools and quality systems.