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

• 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.

• 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.

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.

Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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.