Scientist Qc Operational Compliance

AGC Biologics, a wholly-owned subsidiary of Asahi Glass Company (AGC), is one of the industry leading CDMOs in reliability, technical excellence, and quality — Right and On Time. AGC is a $12B Japanese-owned and publicly traded company based in Tokyo with over 50,000 employees in 30 countries.With facilities in the USA, Japan, Denmark and Germany, AGC Biologics provides fully integrated biopharmaceutical development and manufacturing solutions to clients globally. The Company has proven expertise in delivering custom solutions for the scale-up and cGMP manufacture of protein-based therapeutics for pre-clinical, clinical, and commercial production. AGC Biologics is experiencing growth in customer base and revenue, expanding personnel, development and manufacturing capacity as well as distinguishing itself in the market with unique technology offerings for clients.

**Scientist QC operational compliance **(m/w/d)**

The vacant position as scientist for operational compliance is structured within our quality control (QC) department, which is responsible for testing of raw materials, produced therapeutic proteins for pre-clinical, clinical and commercial use including stability testing for a wide range of different customers coming from around the world.

You will become part of an agile department of highly dedicated QC staff members working closely with the external customers and internal stakeholders like quality assurance, production and development. Your main tasks will be to:
**Responsibilities**:

- Support QC management to maintain and ensure compliance throughout the QC department
- Have an overview of all relevant quality documents within our QMS software with a focus on managing deviation reports during the initial training phase.
- Ensure that QC deviations, root cause investigations and related CAPAs are managed and completed in an efficient and timely manner
- After successful completion of the training phase the scope of the position will be expanded to other areas such as representation of the QC department in inspections and audits, managing change controls and supporting OOS investigation

In this role, you will work intensively with cGMP, quality systems and risk management approaches, and since the site continues to execute new and diverse manufacturing projects, you will have great opportunities to develop your competences within these fields.

**Job Requirements**:

- + 3 years of professional experience in a quality position
- Good knowledge of the relevant GMP guidelines, AMWHV and regulations
- Experience with TrackWise Digital or comparable System
- General knowledge of biotechnology production and relevant QC responsibilities (raw material testing, environmental monitoring (EM), method validation, in-process and release testing in a GMP environment)
- Experience in microbiology related activities (EM, product change over cleanings, bioburden testing) is a plus
- Team-oriented and strong quality awareness
- **Very good German and English skills**:

- **German work permit is mandatory**:

- Ready to take responsibility

**Join an international and agile organization**

AGC Biologics offers a dynamic working place with good opportunities of working with a varied array of tasks and challenges. You will get experience with the way the various departments throughout a contract manufacturing organization interact in order to achieve success. Exciting and challenging assignments will constantly come your way, and you will to a large extent be able to plan your daily work yourself. AGC Biologics offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC Biologic's employees have a flexible attitude and we help each other to reach deadlines together as one team.

**We look forward to hearing from you.**

**AGC Biologics GmbH**
**Czernyring 22**
**69115 Heidelberg**

**Phone**:06221 / 9026-0