Quality Specialist- Cell and Gene Therapy

Job Summary
We are seeking a dedicated and experienced Quality Assurance Specialist to join our team at Kolon TissueGene, Inc. The ideal candidate will play a pivotal role in ensuring the quality and regulatory compliance of our Phase III clinical trials and commercial manufacturing processes. This role requires a deep understanding of GMP standards and a strong ability to oversee vendor and internal quality systems to ensure product integrity and regulatory adherence.

Responsibilities

• Review and verify the completeness and accuracy of vendor documentation, including batch records, protocols, SOPs, QC data, and deviation/investigation reports.
• Provide quality oversight of external vendors such as CMOs, CTLs, and storage, packaging, and distribution facilities.
• Collaborate with Manufacturing and Process Development teams to resolve quality issues related to products and processes.
• Conduct audits to ensure compliance with internal and external procedures and regulatory requirements.
• Write, revise, and review internal procedures to ensure alignment with global regulatory requirements.
• Participate in internal and external meetings to discuss quality and compliance matters.
• Assist in trending and reporting of quality-related KPIs to support the Quality Management System (QMS).
• Support internal quality systems, including deviations, change control, CAPA, and continuous improvement initiatives.
• Assist QC with equipment qualification to support the Quality by Design study, as required.
• Provide regulatory inspection support and perform data audits of CMC documentation for health authority submissions.
• Perform administrative duties, including filing and organizing documentation as needed.
• Participate in ongoing GxP and quality-related training as required.

Requirements

• Bachelor’s degree in biology, chemistry, engineering, or a related field.
• 5 years of experience in GMP biopharmaceutical industry, preferably within cell therapies.
• Strong knowledge of scientific, medical, and regulatory terms.
• Excellent communication and interpersonal skills with the ability to thrive in a fast-paced environment.
• Strong attention to detail and a proactive approach to problem-solving.
• Experience with quality systems and project management with minimal supervision.
• Proficiency in using word processing, spreadsheet, and database software.
• Ability to work collaboratively within cross-functional teams and sustain professional relationships.

Working Conditions

• Work primarily in an office setting with occasional travel (up to 10%) for vendor audits and inspections.
• Some evening or weekend work may be required.

If you're passionate about ensuring the highest quality in biopharmaceutical products and eager to contribute to groundbreaking cell therapies, we encourage you to apply. Join our team at Kolon TissueGene, Inc. to make a meaningful impact on the future of healthcare!

Job Type: Full-time

Pay: $80,000.00 - $90,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible schedule
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: In person

Salary : $80,000 - $90,000