Sterility Assurance Operations Lead

*Job Title:* Sterility Assurance Operating Lead*Location:* Raleigh, NC*Position Overview:*Our client is seeking a dedicated Sterility Assurance Operating Lead to join our team in Raleigh, NC. This role is integral to ensuring the sterility and quality of our pharmaceutical products through rigorous adherence to aseptic processing standards and contamination control strategies.*Key Responsibilities:** *Aseptic Processing Oversight:* Monitor and support aseptic processing operations to ensure compliance with established sterility assurance protocols.* *Environmental Monitoring:* Conduct routine environmental monitoring to detect and address potential contamination risks.* *Documentation and Reporting:* Maintain accurate records of sterility assurance activities, including batch records, media fill protocols, and environmental monitoring reports.* *Training and Mentorship:* Provide training to operational staff on aseptic techniques, gowning procedures, and contamination control measures.* *Continuous Improvement:* Identify opportunities for process enhancements and collaborate with cross-functional teams to implement improvements.* *Regulatory Compliance:* Ensure all activities align with current Good Manufacturing Practices (cGMP) and other relevant regulatory requirements.*Qualifications:** *Education:* Associate Degree in Life Sciences or a related field; equivalent experience will be considered.* *Experience:* Minimum of 1-3 years in a cGMP-regulated environment, preferably within the pharmaceutical or biotechnology industry.* *Technical Skills:* Proficiency in aseptic processing, environmental monitoring, and contamination control strategies. Familiarity with microbiological testing and data analysis is advantageous.* *Soft Skills:* Strong attention to detail, effective communication abilities, and a collaborative mindset.Job Type: ContractPay: $70.00 - $80.00 per hourExpected hours: 40 per weekSchedule:* 8 hour shift* Monday to FridayApplication Question(s):* How many years do you have as a Sterility Assurance specialist or lead?Ability to Commute:* Raleigh, NC 27614 (Required)Ability to Relocate:* Raleigh, NC 27614: Relocate before starting work (Required)Work Location: In person

Created: 2025-03-04