Senior QA Operations Specialist – Night Shift

About the role

Eli Lilly Japan is hiring a Senior QA Operations Specialist for its Seishin plant in Kobe, working night shifts (20:00–08:00, 12-hour rotating schedule). The role covers advanced quality assurance operations: day-to-day QA support for manufacturing and warehouse operations, and proactive leadership of quality events such as deviations, change controls and complaints, including investigations and cross-functional coordination.

Key responsibilities

• Follow safety requirements, take part in safety initiatives such as B-Safe and safety walks, and report safety concerns with corrective actions.
• Review batch manufacturing and testing records, enter data, confirm GMP compliance of storage and inbound/outbound records, and support shipment release decisions.
• Lead deviation investigations with root cause analysis and CAPA, assess change controls, investigate product complaints and coordinate with overseas manufacturing sites.
• Maintain activity planning records, document filing and archives, and prepare and quality-check meeting materials and Annual Product Reviews.
• Draft and revise SOPs, and operate internal systems such as SAP and MURATA accurately.
• Train and guide junior staff, share solutions to operational issues and propose continuous improvement.

Required profile

• Science or engineering background (pharmacy, chemistry, biochemistry, agricultural science) or 3+ years of hands-on experience in manufacturing, QA or quality testing in pharma, chemicals, cosmetics or food.
• Experience handling quality events (deviations, change controls, complaints) including RCA/CAPA, or equivalent investigation work from a production background.
• Ability to make autonomous quality judgments and collaborate with colleagues inside and outside the team.
• Attention to detail and accuracy, multitasking ability, and a team-oriented approach to quality and safety.
• Practical English to read English system screens and documents (TOEIC ~600 or equivalent is a plus, not required).

Required skills

• Word, Excel and PowerPoint at general administrative level.
• Knowledge of the GMP and QMS ministerial ordinances is preferred.

What we offer

• Salary according to company rules, plus housing allowance and commuting expenses.
• Annual performance-based bonus paid in March, and annual leave of about 195 days.
• Health, pension and accident insurance, and housing assistance and company housing.
• 6-month probation with no pay difference, and a career path that may include Kobe headquarters, Tokyo branch or overseas offices.