MQSA Associate Scientist

Johnson & Johnson seeks an MQSA Associate Scientist to support sterilization processes and microbiological quality for medical device products. The role involves coordinating testing activities, managing regulatory compliance, and collaborating with product development teams across two U.S. locations.

Responsibilities

• Coordinate endotoxin testing and dose audit activities including sample procurement and laboratory testing
• Prepare and evaluate trending data while identifying out-of-specification results
• Collaborate with Product Development Teams to establish microbiological quality requirements
• Support requalification activities for Ethylene Oxide sterilization programs
• Maintain compliance with GMP/GDP requirements and prepare change request documentation

Requirements

• Bachelor's degree in Microbiology, Biomedical Science, Engineering, or related field
• Minimum 2 years sterilization or microbiological experience in medical device, pharmaceutical, or food science
• Knowledge of FDA QSR, CMDR, MDD, ISO 13485, ISO 14971, and ISO 9001 regulations
• Microbiology or quality assurance experience with sterile product production
• Fluent English and MS Office proficiency
• Strong analytical, critical thinking, and attention to detail skills