Senior Scientist – MQSA, Supplier/EM

Johnson & Johnson

Microbiological Quality & Sterility Assurance Specialist at Johnson & Johnson, supporting quality assurance activities for medical devices and pharmaceuticals in various locations.

Posted 7/18/2026full-timePalm Beach Gardens • Florida, Massachusetts, Pennsylvania • 🇺🇸 United StatesSenior💰 $92,000 - $148,350 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Microbiological Quality and Sterility Assurance, with a strong focus on contamination control, regulatory compliance, and supplier quality management. Proficient in conducting investigations, audits, and providing technical guidance within the medical device and pharmaceutical industries.

Highest-signal resume keywords

Microbiological Quality AssuranceSterilization ProcessesContamination ControlSupplier AuditsRegulatory Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Microbiological ControlContamination Control StrategiesSterilization Process KnowledgeInvestigation SupportTest Method DevelopmentValidation ExperienceSupplier Quality AgreementsRisk AssessmentCAPA ManagementEnvironmental Monitoring

Soft Skills

Strong CommunicationCollaboration SkillsIndependent WorkRelationship BuildingTeam Contribution

Industry Keywords

Medical Device IndustryPharmaceutical IndustryISO StandardsEN StandardsAAMI StandardsQuality RequirementsCompliance AssessmentsAudit ObservationsDue Diligence ActivitiesCross-Functional Team Support

About the role

Key responsibilities & impact

Supporting end‑to‑end Microbiological Quality & Sterility Assurance (MQ&SA) activities related to suppliers and external manufacturing processes
Contributing to change requests and projects impacting controlled environments, cleaning, and sterilization processes
Supporting contamination control strategies, including environmental monitoring and investigation activities
Providing technical guidance and training on microbiological quality and sterility assurance
Acting as subject matter expert for investigations, CAPA, non‑conformances, audit observations, and risk assessments
Supporting due diligence activities (e.g., acquisitions, partnerships) by providing MQ&SA expertise and risk input
Supporting development and updates of supplier quality agreements
Coordinating and participating in supplier audits, including preparation, on‑site support, response review, and follow‑up activities
Partnering with cross‑functional teams to support supplier qualification and lifecycle management
Contributing to remediation activities following audits or regulatory findings
Building strong relationships with external partners, including manufacturers, suppliers, sterilization providers, and testing laboratories

Requirements

What you’ll need

A minimum of a Bachelor’s Degree in Microbiology, Biological Sciences or Engineering is required
Minimum 4 years of experience with microbiological and sterilization in the medical device and/or pharmaceutical industry is preferred
Strong knowledge of microbiological control, contamination control, and sterilization processes
Familiarity with applicable standards and regulations (e.g., ISO, EN, AAMI)
Experience conducting or supporting investigations, test method development, and validation
Knowledge of regulatory and quality requirements related to suppliers and external manufacturing
Experience supporting audits, inspections, or compliance assessments
Strong communication and collaboration skills, with the ability to work across functions and levels
Ability to work independently while contributing effectively to team objectives
Fluent in English (Spanish is a plus)
Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivity

Benefits

Comp & perks

Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year