Quality Control Partner – Roche

Quality Control Partner is a critical role now open at Roche, a global pioneer in pharmaceuticals and diagnostics. As a Quality Control Partner, you will be at the forefront of ensuring the safety and efficacy of life-saving biological and chemical drug products. This position is located in Hanam, Gyeonggi-do, South Korea, and offers a unique opportunity to join a world-class team dedicated to “Doing now what patients need next.”

Role Overview

The Quality Control Partner will lead and support various analytical activities within the laboratory. From performing advanced testing to managing critical reagents and cell banks, this role requires a blend of technical expertise and a commitment to rigorous quality standards. You will act as a Subject Matter Expert (SME) during method transfers and play a key role in GxP audits.

Key Responsibilities

1. Advanced QC Testing: Executing purity, content, and identity tests using HPLC, UPLC, CE, and cell-based assays.

2. Investigation Management: Leading root cause analysis for OOS/OOT (Out of Specification/Trend) results and implementing effective CAPAs.

3. Method Transfer: Providing technical leadership for internal and external analytical method transfers.

4. Data Integrity: Reviewing raw data and analytical results to ensure strict compliance with GxP documentation practices.

5. Equipment Lifecycle: Coordinating the qualification and maintenance of state-of-the-art laboratory equipment.

Also Check: Senior Biotechnologist Downstream

Qualifications and Requirements

1. Education: A Bachelor of Science degree in Biotechnology, Biochemistry, or a related field.

2. Experience: A minimum of 4 years in pharmaceutical quality control operations.

3. Technical Skills: In-depth knowledge of instrumental analysis (Spectrophotometers, Plate Readers) and complex biological assays.

4. Soft Skills: Strong English communication skills and a proactive mindset toward problem-solving.