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Forge Biologics is seeking an Analyst I, Quality Control (Raw Materials) to join their team at The Hearth, a 200,000-square-foot cGMP manufacturing facility in Columbus, Ohio. The company focuses on enabling access to life-changing gene therapies, particularly AAV vector production for genetic disease treatments.
In this role, you will be responsible for performing incoming inspection and quality control on raw materials used in AAV vector production. You will execute processes defined in Standard Operating Procedures (SOPs) in a cGMP-compliant manner, perform material testing (identity, purity, potency, microbial contamination), and accurately document results according to Good Documentation Practices (GDP).
Key responsibilities include:
- Inspecting all incoming materials for integrity and quality
- Facilitating material testing activities on incoming and Forge-produced raw materials
- Accurately documenting test results, observations, and procedures
- Communicating between departments to ensure operations teams have required materials
- Collaborating with the procurement team on timely receipt and disposition of materials
- Escalating non-conformances or deviations to appropriate channels
- Assisting in development and optimization of practices and procedures
- Contributing to maintenance, calibration, and qualification of laboratory equipment
- Adhering to SOPs, cGMP guidelines, and regulatory requirements
- Maintaining a clean, organized workspace and following safety protocols
The role operates in both warehouse and office environments, with moderate noise levels. You will use computers and standard warehouse equipment (powered industrial trucks, hand trucks). Physical demands include regularly moving freight and materials, lifting/carrying/pushing/pulling objects up to 50 lbs, and moving around the facility for extended periods.
Forge Biologics offers comprehensive benefits including health/dental/vision insurance (90% premium coverage), 12 weeks paid parental leave, competitive PTO, annual bonuses, 401(k) with company match, onsite fitness facility, mental health counseling, and professional development resources.
Requirements:
- Bachelor's Degree in Biology, Biochemistry, Chemistry, or related discipline
Preferred Skills:
- Prior experience in a laboratory or quality control environment
- Understanding of cGMP and regulatory guidelines
Competencies:
- Attention to detail, accuracy, and ability to follow protocols
- Strong organizational and documentation skills
- Effective communication and teamwork ability
- Willingness to learn and adapt to new techniques and technologies
