Quality Compliance Specialist
4 weeks ago
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 as we work side-by-side with our clients and partners, every step of the way.
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 currently employ more than 2,500 employees worldwide.
A Competitive Compensation Package
We offer a highly competitive compensation package that reflects the value you bring to our organization. Based on your qualifications and experience, this role offers an estimated annual salary of $85,000-$110,000, depending on your location within Copenhagen, Denmark.
About the Role
We are seeking a Quality Compliance Specialist to join our Plant Engineering team at our Copenhagen site. As a key member of our team, you will be responsible for ensuring compliance with quality-related tasks such as deviations, technical system changes, CAPAs, and procedures. You will also manage various improvement and system upgrade projects and support technicians, project managers, and engineers in the department with more complex troubleshooting activities.
Your Key Responsibilities
- Cooperate with colleagues within the department and stakeholders from other departments to ensure compliance is maintained at the appropriate level.
- Handle quality documents such as deviations, change controls, CAPAs, and procedure updates, working alongside your team members.
- Familiarize yourself with related technical systems to manage tasks independently.
- Contribute to the continuous improvement of our utilities, facilities, and systems, ensuring that these improvements are implemented within the quality system.
- Present documentation during audits and inspections.
Your Profile
- Relevant technical background as an engineer or equivalent technical experience in the pharmaceutical or process industry is required.
- Knowledge of GMP is preferable, along with experience in operations, maintenance, or project participation, and most importantly, a passion for working with quality-related documentation.
- You are pragmatic and flexible, with a strong focus on achieving goals and a personal drive to complete tasks effectively.
- You have a structured approach to planning and executing tasks.
- Good communication skills, including the ability to communicate clearly in both written and spoken English and Danish, are preferred.
Our Culture
At AGC Biologics, our culture is defined by six core values: Knowledge, Trust, Quality, Ingenuity, Accountability, and Teamwork. These values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.
Join Our Global Network
With locations across three continents, we offer a unique opportunity to collaborate with diverse teams and contribute to the development of life-changing therapies. If you are passionate about quality and compliance, and want to make a difference in the lives of patients, apply now to become part of our global network.
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