QA Scientist, Mammalian Biologics - Batch Release Lead

AGC Biologics; København; On-site; DKK 520,000 - 680,000; Full time

Job summary

AGC Biologics is seeking a QA Scientist to support GMP-compliant manufacturing and batch release within the QA Mammalian team. The role emphasizes quality oversight and timely disposition of batches, ensuring compliance with EU GMP, 21 CFR and ICH guidelines.

You will review GxP documents, support CAPAs, deviations, change controls, DS specifications, Master Production Records, and risk assessments, while contributing to SOP improvements and QA projects.

Qualifications

• Master's degree with at least two years in Quality Assurance.
• Or extensive GMP background with five years in QA.
• Experience in biopharma or CDMO is advantageous.

Responsibilities

• Batch review and release activities with QA oversight.
• QA review/approval of GxP documents (change controls, deviations, CAPAs, DS specifications, MBRs, risk assessments).
• Support generation or improvement of SOPs and QA projects.
• Possible support for client audits.

Skills

Quality Assurance

GMP knowledge

Documentation

Communication

Education

Master's degree in relevant field

Job description

AGC Biologics is seeking a QA Scientist to support GMP-compliant manufacturing and batch release within the QA Mammalian team. The role emphasizes quality oversight and timely disposition of batches, ensuring compliance with EU GMP, 21 CFR and ICH guidelines.

You will review GxP documents, support CAPAs, deviations, change controls, DS specifications, Master Production Records, and risk assessments, while contributing to SOP improvements and QA projects.