Senior Scientist, Quality Assurance

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

Would you like to be a part of AGC Biologics' growing success?
We are looking for a QA Scientist with a strong interest in qualification of GMP Facilities, Equipment and Computerized Systems!

The Quality Assurance department:
You will be joining the Quality Assurance department, consisting of over 80 colleagues, with primary responsibilities in Manufacturing, Raw Materials, Quality Control, and Facilities and Equipment. The Quality Assurance Facilities and Equipment team is comprised of highly qualified scientists with diverse professional backgrounds and several years of experience in the field of Quality Assurance.

The main objective of the team is to ensure that our production facilities and laboratories comply with current Good Manufacturing Practice (GMP) standards, including EU GMP, 21 CFR, and ICH guidelines at all times.

The team is mainly responsible for the review and approval of quality documentation, including equipment qualifications, IQ, OQ, PQ, environmental monitoring, cleaning validation, deviation handling, and approval of CAPA and change requests.

The QA Scientist position:
As the QA Scientist, you will be a vital member of a highly motivated, multidisciplinary team. Your daily responsibilities will include:

• Overseeing the Quality Assurance review and approval of all technical documents, including but not limited to:
  • Change Controls
  • Deviations
  • CAPAs
  • Risk assessments
  • SOPs
  • Validation Plans
  • Requirements Specifications
  • Qualification Protocols and Reports
• Conducting GEMBA walks in GMP areas
• Communicating with internal and external stakeholders to resolve and clarify any points of issue
• Be part of setting standard for Qualification, Calibration, EM, cleaning and other Facility and engineering activities

Your profile - education and experience:
It is crucial to possess a self-motivated personality with a practical approach to daily tasks, while maintaining a commitment to quality. Our working environment is dynamic and demanding, necessitating the capability to problem-solve, fulfill commitments, and provide a favorable experience for our clients.

The ideal candidate should possess the following qualifications

• A science-based degree
• Experience working in or directly supporting manufacturing operations in a drug substance/product manufacturing site
• Prior biopharmaceutical experience is desirable
• Thorough understanding of Good Manufacturing Practice (GMP) principles and guidelines
• Experience with the qualification of GMP facilities, equipment, and computerized systems
• Knowledge of Data Integrity principles
• Strong decision-making skills and a proactive attitude
• Excellent written and verbal communication skills
• Ability to work efficiently in a fast-paced, matrix environment
• Ability to meet deadlines and effectively manage multiple tasks
• Flexibility to adapt to changing business needs and priorities.

At AGC, we serve international clients and English is our company language. As such, professional proficiency in both written and spoken English is a requirement.

Your application:
We continuously assess incoming applications and schedule interviews accordingly. To ensure prompt consideration, please submit your application and resume promptly. The advertisement will be closed once the ideal candidate has been identified.

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.

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. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.
Location: Copenhagen Site