MQSA Associate Scientist

Johnson & Johnson

. Support endotoxin testing and dose audit activities for external suppliers by coordinating sample procurement, sterilization activities and laboratory testing .

Posted 10/16/2026full-timeUnited StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in microbiological quality assurance and sterilization processes, ensuring compliance with FDA regulations and industry standards. Proficient in data analysis and documentation related to sterilization and quality control in medical device and pharmaceutical sectors.

Highest-signal resume keywords

Sterilization ProcessesMicrobiological Quality AssuranceGMP/GDP ComplianceFDA RegulationsAnalytical Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

MicrobiologySterilizationQuality AssuranceData AnalysisStandard Operating ProceduresTest Report WritingAttention to DetailRegulatory ComplianceChange Request ProcessesContamination Prevention

Soft Skills

TeamworkInterpersonal SkillsCritical Thinking

Tools & Technologies

MS OfficeSterilization Technologies

Industry Keywords

Medical DevicePharmaceuticalFood ScienceISO 13485ISO 14971ISO 9001CGMPCGLPCanadian Medical Device RegulationMedical Device Directive

About the role

Key responsibilities & impact

Support endotoxin testing and dose audit activities for external suppliers by coordinating sample procurement, sterilization activities and laboratory testing
Prepare and evaluate trending data and increase awareness of out-of-specification results
Work with Product Development Teams to establish and meet microbiological quality requirements based on customer and regulatory needs
Support requalification activities for a compliant Ethylene Oxide sterilization program
Prepare and route documents for change request/change order processes
Comply with GMP/GDP requirements and guidelines
Implement and maintain sterilization processes to ensure product safety, quality, contamination prevention and efficacy
Collaborate with scientists and work with innovative sterilization technologies

Requirements

What you’ll need

Bachelor’s degree in Microbiology, Biomedical Science, Engineering, Sterility Assurance, Food Science or related field is preferred
Minimum of 2 years of sterilization/microbiological experience in the medical device, pharmaceutical and/or food science industries
Experience in the field of microbiology or quality assurance, in the production of sterile products
Fluent in English
MS Office skills
Strong teamwork and interpersonal skills
Analytical and critical thinking skills with strict attention to detail
Solid understanding of applicable FDA (QSR) regulations, Canadian Medical Device Regulation (CMDR), Medical Device Directive (MDD), ISO 13485, ISO 14971 and ISO 9001 is strongly preferred
Experience writing standard operating procedures, protocols, and test reports is preferred
Knowledge of EU, FDA, cGMP and cGLP regulations is strongly preferred

Benefits

Comp & perks

Inclusive work environment
Equal opportunity employment
Interview process accommodations for applicants with disabilities
Up to 5% domestic travel may be required