Quality Control Staff, Innovative Medicine (Fuji Plant)

About the role

Johnson & Johnson is hiring a Quality Control staff member for its Innovative Medicine business at the Fuji plant in Shizuoka. The role covers the implementation, improvement and harmonization of laboratory quality systems in line with GMP/GCTP and J&J quality guidelines, and leads QC activities for new product launches.

Key responsibilities

• Ensure laboratory operations comply with GMP/GCTP, the Narcotics and Psychotropics Control Law, the Japanese Pharmacopeia, the Pharmaceutical and Medical Device Act and chemical substance regulations.
• Lead the transfer of analytical methods between other sites and the Fuji site, and lead QC activities for new product launches.
• Confirm that all laboratory systems meet GMP/GCTP, J&J guidelines and quality standards, including support for regulatory filings and sub-system owners.
• Support laboratory system activities such as stability program administration, analytical change control, Empower and training.
• Lead and support lab projects that improve efficiency, throughput, cost, cycle time, inventory and error rates.
• Complete required GMP/GCTP, EHS and role-related training, and proactively support compliance, audit readiness and risk identification.

Required profile

• Bachelor's degree or equivalent in science, chemistry, biology, biotechnology, microbiology or a related field.
• More than 3 years of experience in the pharmaceutical industry.
• Experience in laboratory or laboratory systems work under GMP-compliant conditions.
• Good written and spoken English.

Required skills

• GMP/GCTP and data integrity knowledge.
• Pharmaceutical regulations, standards and guidelines.
• Analytical testing, instrument analysis and equipment management.
• Documentation (SOP, WI, lab worksheets, assessments).
• Basic PC software such as Microsoft Office and analytical software such as Empower.