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← Forge Biologics

Specialist I, QA Operations

Forge Biologics
Location
Columbus, Ohio
Posted
1 month ago
Department
Quality Management
What they actually want (must-haves)
  • 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
  • Ability to collaborate with cross-functional technical groups
  • Strong communication skills
  • Ability to work necessary hours to support production and participate in an on-call rotation
Nice to have
  • Direct experience in providing QA support for cGMP manufacturing operations in a cleanroom environment
  • Experience working in the production of biologics (ex. gene therapies)
  • Knowledge of cGMP regulations, quality systems, and quality assurance principles
  • Experience utilizing an eQMS, preferably Veeva Vault or another document management system
  • Intermediate proficiency in Microsoft Office applications
What the job really is

The Specialist I, QA Operations at Forge Biologics is responsible for ensuring compliance with regulatory requirements and maintaining quality standards in AAV gene therapy manufacturing. Daily activities include overseeing operations in a cleanroom environment, performing batch record reviews, training manufacturing personnel on quality topics, and collaborating with cross-functional teams to support continuous process improvements. The role also involves preparing for audits and maintaining documentation control processes.

Benefits
  • Health, dental and vision insurance starting day one with 90% of premiums covered
  • Competitive paid time off plan
  • 12 weeks of fully paid parental leave
  • Annual bonus opportunities for full-time team members
  • 401(k) with company match
  • Special employee discounts, including childcare and dependent care savings
Things to weigh
  • The role requires working in a cleanroom environment and wearing PPE, which may not be suitable for everyone.
  • The job involves participation in an on-call rotation, which may affect work-life balance.
Job score3.2/5
Benefits5/5
Freshness3/5
Career value4/5
Role clarity4/5
Pay transparency0/5

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