Contamination Control and Sterility Assurance Sr. Specialist

The Contamination Control Specialist is responsible to provide expertise and oversight for sterility assurance at site level; including to develop, implement, and maintain contamination control strategies and sterility assurance protocols as directed by Contamination Control and Sterility Assurance management.

This position reports to the Sr. QA Manager Contamination Control and Sterility Assurance US Region and is part of the Contamination Control and Sterility Assurance group located in Duncan, South Carolina and will be an on-site role. 

What you will do:

• Responsible for the sterility assurance program at site level. This includes dose audit program and provide expertise for transfer of work and capacity expansion projects.
• Monitor and evaluate sterility assurance and contamination control performance, and identifying areas for improvement.
• Analyze data and utilize statistical tools to assess process performance and improve outcomes.
• Support non-conformance, investigations,CAPAs, and change control processes related to contamination controls and sterility assurance.
• Ensure compliance with regulatory requirements and industry standards for sterility and contamination control. Including to conduct risk assessments and develop mitigation strategies related to contamination control.

Who you are:

• Bachelor’s degree in microbiology, biology, pharmaceutical sciences, or a related field.
• Minimum of 5 years of experience in contamination control and sterility assurance within the pharmaceutical, biotechnology, or medical device industries.
• In-depth knowledge of regulatory requirements and industry standards for sterility assurance and contamination control (e.g., FDA, EMA, ISO).
• Proven experience in developing and implementing sterility assurance programs and contamination control strategies.
• Strong analytical and problem-solving skills, with the ability to identify and address areas for improvement.

Travel, Motor Vehicle Record & Physical/Environment Requirements: if applicable for role

• Ability to travel occasionally within territory or locations

It would be a plus if you also possess previous experience in:

• Sterilization Standards and Regulations
• Microbiology Laboratory