Forge Biologics
Specialist I, QA Operations (2nd Shift)
Columbus, Ohio
Sponsorship not specifiedDetected 1 day ago
Process ImprovementGMPCRISPRCommunicationMentoring
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About the role
- We are currently seeking a Specialist I, QA Operations (AAV Manufacturing) to join the Forge Biologics Team.
Responsibilities
- Perform detailed review and approval of batch records and associated documentation for AAV gene therapy manufacturing, logbooks, and other controlled documentation ensuring adherence to established procedures and cGMP regulations.
- Collaborate with cross-functional teams, including Process Development, Analytical Development, and Manufacturing, to support continuous process improvement initiatives and ensure alignment with quality objectives.
- Support the documentation control process for AAV gene therapy manufacturing, including reviewing and revising SOPs, work instructions, and forms to ensure compliance with regulatory requirements and industry best practices.
- Th is role will support the Quality Assurance team in activities such as document control, batch record review, and helping maintain a QA presence in AAV gene therapy manufacturing areas.
Requirements
- Bachelor's Degree in a scientific or related field (or equivalent experience).
- Previous experience in a quality assurance role within the pharmaceutical or biotechnology industry.
- Proven track record of keen attention to detail, consistently ensuring accuracy and precision in all tasks and documentation, managing multiple priorities in a fast-paced environment
- Strong communication skills, including the ability to effectively communicate quality issues to senior management.
- Ability to work in a GMP cleanroom environment as needed to support manufacturing operations, which includes wearing required PPE such as gowns, gloves, masks, and safety glasses.
- Ability to collaborate with cross-functional technical groups to resolve issues, close gaps, and ensure compliant outcomes which are efficient and robust.
- Ability to work the hours necessary to support production and participate in an on-call rotation providing off-hours support for AAV manufacturing needs and issues.
- Direct experience in providing QA support for cGMP manufacturing operations in a cleanroom environment.
Nice to have
- Preferred Skills:
Skills
- Experience working in the production of biologics (ex. gene therapies).
- K nowledge of cGMP regulations, quality systems, and quality assurance principles. <span data-cc
- Your Future with Us:
- to enable access to life-changing gene therapies and help bring them from ideas into reality.
- At Forge, your growth matters.
Company info
- Forge Your Future with Us: 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.
- Here, you won't just watch innovation happen - you'll be part of it.
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This listing is sourced directly from Forge Biologics's careers page and normalized into a canonical job model.