Quality Systems Specialist
1 day ago
The Quality Systems Specialist is a key member of the Forge Biologics team, responsible for providing quality systems and operational expertise for the Forge GMP facility in Grove City, OH. This role requires expertise in authoring, reviewing, and approving quality events such as deviations, CAPAs, change controls, and investigations.
The ideal candidate will have a strong background in quality systems, regulatory compliance, and biopharmaceutical manufacturing. They will be responsible for monitoring and improving the internal quality systems policies and workflows at Forge.
Key Responsibilities:
- Provide quality systems and operational expertise for the Forge GMP facility
- Author, review, and approve quality events such as deviations, CAPAs, change controls, and investigations
- Monitor and improve internal quality systems policies and workflows
- Collaborate with cross-functional teams to resolve quality-related issues
Requirements:
- Bachelor's Degree in a biological or STEM-related field (or equivalent work experience)
- Strong expertise in deviation management processes, including root cause analysis and CAPA implementation
- Thorough knowledge of Good Documentation Practices (GDP) and cGMP regulations
- Experience in a GxP environment
- Self-motivated, organized, and proactive
Preferred Skills:
- Experience with root cause analysis and investigations, including technical writing skills
- Working knowledge of global pharmacopeias such as USP, EP, JP, BP, Ph. Eur.
- Knowledge of biopharmaceutical manufacturing process workflows
- Experience supporting inspections performed by FDA and foreign Regulatory Authorities
What We Offer:
- Competitive salary and benefits package
- Opportunities for professional growth and development
- Collaborative and dynamic work environment
- Recognition and rewards for outstanding performance
How to Apply:
Interested candidates should submit their resume and cover letter to [insert contact information].
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