Biologics Quality Assurance Specialist

5 hours ago


Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time
About the Role

We are seeking an experienced Biologics Quality Assurance Specialist to join our QMS & Training team in the Quality Systems department. As a key member of our team, you will collaborate with partners and drive improvement projects optimizing our GMP Training standards and systems.

Your primary responsibility will be to develop new training standards, courses, and programs to support business needs and goals. You will work closely with our trainers and subject matter experts to ensure high-quality training content and delivery.

Key Responsibilities
  • Develop and implement GMP training standards and systems, including the Training Management System, Trainer program, and TWI based Work Instructions program.
  • Collaborate with cross-functional teams to design and deliver training programs that meet business needs.
  • Work closely with trainers and subject matter experts to develop high-quality training content.
  • Drive continuous improvement initiatives to optimize GMP training processes and systems.
Requirements
  • Bachelor's degree in a relevant field (e.g., quality assurance, biology, chemistry) and substantial experience in GMP-regulated environments.
  • Proven experience in planning and executing projects, with a focus on quality and compliance.
  • Strong facilitation and communication skills, with the ability to work effectively with diverse stakeholders.
  • Familiarity with eLearning development tools, particularly Articulate Rise and Storyline.
  • A team-oriented approach, with a strong commitment to quality and customer satisfaction.
  • Effective verbal and written communication skills in English, with Danish proficiency a plus.
Our Culture

At AGC Biologics, we value knowledge, trust, quality, ingenuity, accountability, and teamwork. We offer a collaborative culture that fosters personal initiative and professional achievement.

As a Biologics Quality Assurance Specialist, you will be part of a dynamic team that is passionate about delivering high-quality products and services. If you are a motivated and detail-oriented individual who thrives in a fast-paced environment, we encourage you to apply for this exciting opportunity.



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