QA Specialist (m/f/d)

QA Specialist (M/F/D)

As a Quality Assurance Associate, you will report directly to the Quality Assurance Supervisor and be responsible for ensuring compliance and quality oversight of shop floor activities throughout the manufacturing process.

The Quality on the Shop Floor Associate acts as the Quality Assurance representative for routine GMP (Good Manufacturing Practices) shop floor activities within Drug Substance (Bulk) and Aseptic Filling (Fill & Finish) production areas for biological products.
You will work closely with operational teams to ensure the consistent production of high-quality products, while proactively identifying improvement opportunities and reducing compliance risks.

Tasks :

• Review production-related documentation in manufacturing areas (e.g., batch records)

• Observe critical shop floor activities and support real-time issue resolution; provide continuous QA presence in production areas and collaborate with manufacturing teams to implement actions ensuring product quality

• Support compliance with GMPs and internal procedures by establishing and maintaining a strong partnership between Quality and Operations

• Coach operational teams in the management of quality events

• Collaborate with shop floor teams to support problem-solving and root cause identification for deviations

• Perform planned and unplanned shop floor walkthroughs to ensure process adherence and identify improvement opportunities

• Act as the primary Quality point of contact within production areas

• Proactively identify potential quality risks in collaboration with Production teams

Qualification:

• Technical or scientific academic background

• 2–3 years of experience in a cGMP environment within Quality Operations or Manufacturing on a pharmaceutical site producing sterile injectable products

• Knowledge of manufacturing processes from cell culture to aseptic filling, including unit operations, equipment, gowning, and environmental monitoring

• Has a strong affinity for working directly in production areas

• Works collaboratively with partners, coaches teams, and gives clear meaning to Quality requirements

• Acts as a partner to Production without replacing their responsibilities

Requirements:

Start : 02.03.2026