Analyst I, QC Raw Materials

Forge Biologics

Columbus (OH)

On-site

USD 55,000 - 75,000

Full time

4 days ago
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Benefits offered by this job

Health insurance
Paid time off
Parental leave (12 weeks)
Annual bonus opportunities
401(k) with company match
Employee discounts
Onsite fitness facility
Employee Assistance Program (EAP)
Disability coverage
Free snacks & beverages

Job summary

Forge Biologics is seeking an Analyst I, Quality Control (Raw Materials) to perform incoming inspection of raw materials used in AAV vector production. You will execute SOP-defined processes in a cGMP environment and compare results against criteria, communicating findings clearly to ensure product safety.

Your responsibilities include inspecting materials, coordinating with teams, supporting material testing, documenting results, and assisting with procedures and equipment calibration.

Qualifications

  • Experience in a lab or quality control setting.
  • Familiarity with cGMP and regulatory guidelines.
  • Strong documentation and data recording abilities.

Responsibilities

  • Inspect incoming raw materials for integrity and quality.
  • Coordinate with departments to ensure material readiness.
  • Support material testing for identity, purity, potency, and contamination.
  • Document test results and observations per GDP.
  • Escalate non-conformances and assist in investigations.
  • Assist with SOP development and equipment calibration/qualification.
  • Adhere to SOPs, GDP, and regulatory requirements.
  • Maintain a clean, safe workspace.

Skills

Laboratory experience
cGMP understanding
Documentation skills
Attention to detail
Team communication

Education

Bachelor’s Degree in Biology/Biochemistry/C Chemistry

Job description

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 ofH.O.P.E.We arehardworking, showing up each day with determination and grit. We areopen, creating a space where ideas flow freely, and every voice is valued. We arepurpose-driven, with every task directly tied to changing lives. And we areengaged, 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.

About The Role:

We are currently seeking an Analyst I, Quality Control (Raw Materials) to join the Forge Biologics team. In this role, you will be responsible for performing incoming inspection to evaluate raw materials used in AAV vector production against all Forge defined requirements. Your work will involve executing various processes defined within SOP documents in a cGMP compliant manner. Additionally, you will be responsible for performing comparisons between measured results and expected criteria and communicating those comparisons in a timely and thorough way. Your contribution will be essential in maintaining the integrity and safety of our gene therapy products.

Responsibilities:
  • Inspect all materials that arrive at the facility for integrity and quality.
  • Communicate between departments to ensure operations teams have all required materials.
  • Facilitate a range of activities to support material testing, including but not limited to identity, purity, potency, and microbial contamination, on incoming and Forge produced raw materials.
  • Accurately document test results, observations, and procedures in accordance with Good Documentation Practices (GDP).
  • Collaborate with the procurement team to ensure timely receipt and disposition of raw materials.
  • Escalate any non-conformance or deviations to appropriate channels for investigation and resolution.
  • Assist in the development and optimization of practices and procedures.
  • Contribute to the maintenance, calibration, and qualification of laboratory equipment.
  • Adhere to Standard Operating Procedures (SOPs), cGMP guidelines, and regulatory requirements.
  • Maintain a clean and organized work space and adhere to safety protocols.
Qualifications:
  • Bachelor’s Degree in Biology, Biochemistry, Chemistry or a related discipline.
Preferred Skills:
  • Prior experience in a laboratory or quality control environment.
  • Understanding of cGMP and regulatory guidelines.
  • Attention to detail, accuracy, and the ability to follow protocols.
  • Strong organizational and documentation skills.
  • Effective communication and ability to work within a team.
  • Willingness to learn and adapt to new techniques and technologies.

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 warehouse and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The noise level is usually moderate. This role utilizes a computer and other standard warehouse equipment such as powered industrial trucks and hand trucks. Regularly moves freight, stock, or other materials to and from storage or production areas, loading docks, delivery vehicles. Must be able to lift, carry, push, and/or pull objects weighing up to 50 lbs. Regularly communicate with others in person and electronically. Must have the ability to move around the facility for extended periods of time.

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.
  • 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.
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