QC Coordinator

1 month ago

Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time
Job Title: QC Coordinator

We are seeking a highly skilled QC Coordinator to join our team at AGC Biologics. As a key member of our Quality Control department, you will play a critical role in ensuring the quality and integrity of our biopharmaceutical products.

About the Role:

The successful candidate will be responsible for coordinating and planning analytical QC activities, supporting clinical and commercial manufacturing for our customers worldwide. You will work closely with our cross-functional teams to ensure seamless execution of projects and maintain high-quality standards.

Key Responsibilities:
  • Represent QC in projects, project core teams, and customer meetings
  • Be the primary point of contact for QC-related matters
  • Lead cross-QC analytical project teams
  • Maintain knowledge and overview of QC project milestones and batch release schedules
  • Coordinate and ensure the timeliness of analytical method validations in collaboration with QC subject matter experts
  • Be responsible for specification ownership, including establishment and update of specifications
  • Drive the in-house transfer of analytical methods from analytical development to QC
  • Build and maintain relationships with internal and external stakeholders
  • Write and review GMP documentation, including CR cases, CAPAs, and deviations, CoAs, and analytical set-ups
  • Participate in regulatory inspections, such as DMA, FDA, and customer audits
  • Advise management on QC strategic matters
Requirements:
  • MSc in Chemistry, Biochemistry, or a relevant field with 2-6 years of relevant experience or a PhD with 3 years of relevant experience
  • Fluent in written and spoken English
  • Strong analytical and problem-solving skills
  • Excellent communication and interpersonal skills
  • Ability to work in a fast-paced environment and prioritize multiple tasks
About AGC Biologics:

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan.

We are an equal opportunity employer and welcome applications from diverse candidates. If you are a motivated and detail-oriented individual with a passion for quality and excellence, we encourage you to apply for this exciting opportunity.

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