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Manufacturing Quality Assurance Specialist

3 weeks ago


Copenhagen, Copenhagen, Denmark AGC Inc Full time

At AGC Biologics, we are committed to delivering high-quality biopharmaceutical products to patients around the world. We are seeking a highly skilled QA Manufacturing Support Technician to join our team in Copenhagen, Denmark.

About the Role

The QA Manufacturing Support Technician will be responsible for ensuring the quality of our manufacturing processes and products. This will involve reviewing batch records, providing real-time review of manufacturing records and logbooks, and collaborating with cross-functional teams to ensure compliance with GMP requirements.

Key Responsibilities
  • Support manufacturing during batch production record reviews with good documentation practice-related queries.
  • Review and approve buffer and media batch production records.
  • Print batch process records.
  • Manage manufacturing labels.
Qualifications and Experience
  • Bachelor's degree in Laboratory Technology or a related field.
  • Preferably experience from a GMP production environment or QA department within the biopharmaceutical industry.
  • Familiarity with reviewing batch production records (BPRs) and solution preparation sheets.
  • Excellent collaboration and communication skills.
  • Fluency in written and spoken English.

We offer a dynamic work environment, opportunities for growth and development, and a competitive compensation package. If you are a motivated and detail-oriented individual with a passion for quality assurance, please submit your application and CV.