MQSA Scientist: Microbiology Quality & Sterility

6029-MEDICAL DEVICE BUSINESS SERVICES, INC. Legal Entity; West Chester (Chester County); On-site; USD 76,000 - 122,000; Full time

Benefits offered by this job

401(k) plan

Pension plan

Vacation and paid time off

Parental Leave

Holiday pay

Job summary

Johnson & Johnson in West Chester, PA is seeking an MQSA Scientist to lead microbiological quality, sterilization, and reprocessing efforts across development and manufacturing. This site SME will strengthen microbial controls and support patient safety while collaborating with a talented team of scientists and engineers.

The role requires a degree in microbiology or related field, 2+ years in sterilization/microbiology, knowledge of GMP/GDP and FDA QMSR standards, and strong teamwork skills.

Qualifications

• Bachelors degree in Microbiology or related field.
• Minimum of 2 years of sterilization/microbiological experience in medical devices/pharma/food industries.
• Experience with FDA regulations (QMSR) and quality systems.

Responsibilities

• Ensure microbiological quality requirements meet customer and regulatory needs.
• Develop/validate sterilization methods and reprocessing instructions.
• Coordinate EO sterilization requalification activities and non-conformance investigations.
• Prepare and review change requests, SOPs, validation protocols/reports.
• Ensure GMP/GDP compliance and maintain quality documentation.

Skills

Sterilization

Microbiology

Quality Assurance

Regulatory Compliance

Data Analysis

MS Office

Education

Bachelor's degree in Microbiology or related

Job description

Johnson & Johnson in West Chester, PA is seeking an MQSA Scientist to lead microbiological quality, sterilization, and reprocessing efforts across development and manufacturing. This site SME will strengthen microbial controls and support patient safety while collaborating with a talented team of scientists and engineers.

The role requires a degree in microbiology or related field, 2+ years in sterilization/microbiology, knowledge of GMP/GDP and FDA QMSR standards, and strong teamwork skills.