QA Specialist- Contamination Prevention & Control

Be the driving force behind seamless quality assurance for a global CMO, where precision and efficiency are key to supporting world-class manufacturing.

Proclinical is seeking a QA Specialist to support contamination prevention and control strategies within manufacturing and support units. This role focuses on premises and utilities qualification, ensuring compliance with regulatory requirements and internal quality standards. You will play a key role in maintaining facilities and utilities in a qualified and controlled state.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

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.

Key Skills and Requirements:

• Bachelor's degree in a relevant scientific discipline, preferably microbiology.
• Practical knowledge of performance qualification for manufacturing facilities, clean rooms, 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.