Analyst I, QC Raw Materials

The role

The Analyst I, Quality Control (Raw Materials) will perform incoming inspection to evaluate raw materials used in AAV vector production. This role involves executing processes defined in SOP documents in a cGMP compliant manner and communicating results against expected criteria.

What you will do

• Inspect all materials that arrive at the facility for integrity and quality.
• Communicate between departments to ensure operations teams have all required materials.
• Facilitate activities to support material testing including identity, purity, potency, and microbial contamination.
• 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.
• 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.

Required qualifications

• Bachelor’s Degree in Biology, Biochemistry, Chemistry or a related discipline.
• 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.
• Must be able to lift, carry, push, and/or pull objects weighing up to 50 lbs.
• Must have the ability to move around the facility for extended periods of time.

Nice to have

• Prior experience in a laboratory or quality control environment.
• Understanding of cGMP and regulatory guidelines.

Benefits

• Health, dental and vision insurance start your first day with 90% of premiums covered for you and your family.
• 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 Employee Assistance Program.
• Employer-paid short and long-term disability coverage.
• Fully stocked kitchen with free snacks and beverages.
• Ongoing professional development resources, training, and mentorship programs.

About the company

Forge Biologics aims to enable access to life-changing gene therapies. The team works out of The Hearth, a 200,000-square-foot cGMP facility in Columbus, Ohio.