QA Specialist- Contamination Prevention & Control

Drive Seamless Quality Assurance for Global Manufacturing

Be the driving force behind precision and efficiency in supporting world-class manufacturing. This role focuses on contamination prevention and control strategies within manufacturing and support units, ensuring that facilities and utilities remain in a qualified and controlled state. You will play a key role in maintaining compliance with regulatory requirements and internal quality standards for a global CMO.

Key Responsibilities

• Provide quality oversight for the qualification of manufacturing facilities, including environmental monitoring and clean utility systems.
• Ensure facilities and quality systems comply with internal standards and applicable regulations.
• Develop action plans to address deficiencies and maintain microbiological quality across site facilities, utilities, processes, and products.
• Analyze environmental monitoring data, identify trends, and implement corrective actions as needed.
• Collaborate with cross-functional teams to meet contamination prevention requirements for new product introductions, facility changes, and process adaptations.
• Lead investigations into contamination incidents, monitoring excursions, and deviations from procedures.
• Offer microbiological expertise to support investigations, CAPAs, and change controls related to contamination control.
• Support regulatory inspections and customer audits as a subject matter expert in pharmaceutical microbiology.

Essential Skills and Requirements

• Bachelor's degree in a relevant scientific discipline, preferably microbiology.
• Practical knowledge of performance qualification for manufacturing facilities, cleanrooms, and clean utility systems.
• Experience in GMP environments within the biologics industry, particularly in Quality Assurance or Quality Control Microbiology.
• Strong understanding of contamination control principles, practices, and regulatory requirements (FDA, EMA).
• Familiarity with microbiological testing methods, environmental monitoring, cleanroom qualification, and microbiological control strategies.
• Excellent written and verbal communication skills, with attention to clear and accurate documentation.
• Ability to work effectively in a fast-paced environment, both independently and collaboratively.
• Strong problem-solving abilities and decision-making skills.
• A proactive mindset with the ability to prioritize tasks based on business needs.
• Right to work in the specified location or hold an EU passport.