Microbiology Quality & Sterility Scientist

Antler; Warsaw (IN); On-site; USD 76,000 - 122,000; Full time

Benefits offered by this job

Vacation time

Sick time

Holiday pay

Parental Leave

Bereavement Leave

Military Spouse Time-Off

Job summary

Johnson & Johnson, a leader in healthcare innovation, is recruiting a Microbiology Quality & Sterility Assurance (MQSA) Scientist for multiple U.S. sites, including West Chester, PA; Palm Beach Gardens, FL; Warsaw IN; Raynham, MA.

This role focuses on microbiological quality, sterilization, and reprocessing within DePuy Synthes during a planned separation process. The MQSA Scientist partners with product development and manufacturing teams, applying scientific expertise to strengthen

Qualifications

• Bachelor's degree in Microbiology or related field.
• Minimum 2 years of sterilization/microbiological experience in medical devices/pharma/food science.
• Solid understanding of FDA regulations (QMSR).
• Experience in microbiology or quality assurance for sterile products.
• MS Office skills are required.
• Strong teamwork and analytical skills with attention to detail.
• Knowledge of EU, cGMP and cGLP regulations preferred.

Responsibilities

• Establishes and ensures microbiological quality requirements meet customer and regulatory needs.
• Develops radiation sterilization validations or product adoptions.
• Develops/validates reprocessing instructions for reusable medical devices.
• Coordinates EO sterilization program requalification activities.
• Investigates non-conformances and implements corrective actions.
• Prepares and evaluates trending data and investigates OOS results.
• Manages documentation for change requests and validation reports.
• Ensures GMP/GDP compliance.

Skills

Sterilization experience

FDA regulations

Microbiology knowledge

MS Office

Teamwork

Attention to detail

Education

Bachelor's degree in Microbiology or related field

Job description

Johnson & Johnson, a leader in healthcare innovation, is recruiting a Microbiology Quality & Sterility Assurance (MQSA) Scientist for multiple U.S. sites, including West Chester, PA; Palm Beach Gardens, FL; Warsaw IN; Raynham, MA.

This role focuses on microbiological quality, sterilization, and reprocessing within DePuy Synthes during a planned separation process. The MQSA Scientist partners with product development and manufacturing teams, applying scientific expertise to strengthen