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.
- Expertise risk assessment tools and quality systems.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change, or new ones may be assigned.
Work Environment and Physical Demands 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. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area.
We've Got You Covered: At Forge Biologics, we believe our people deserve to be taken care of - in and out of the workplace. We've built a comprehensive compensation and benefits package designed to help you thrive, grow, and feel valued every step of the way:
Health from day one- Health, dental and vision insurance start your first day - with 90% of premiums covered for you and your family.
Time to recharge- A competitive paid time off plan - because rest fuels innovation.
- 12 weeks of fully paid parental leave so you can focus on family when it matters most.
Rewarding your impact- Annual bonus opportunities for all full-time team members.
- 401(k) with company match to help you plan for the future.
- Special employee discounts, including childcare and dependent care savings.
Your wellness, supported- 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 to protect your peace of mind.
Fuel for your workday- A fully stocked kitchen with free snacks and beverages - we keep you energized and ready for what's next.
Grow with us- Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.
