Quality Assurance Associate at Eli Lilly

Job Description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Responsibilities

Mainly responsible for sample analysis, assessment of product complaint information, and related activities for product complaints reported mainly from the Asia-Pacific region.

Sample Analysis

Open and receive returned complaint samples and prepare them for analysis.
Perform visual and/or functional analysis of returned complaint samples.
Assess the results of the returned complaint sample, including impact on complaint level, complaint categories, investigation site, and additional investigation requirements.
If further investigation is required, assign and forward the returned complaint sample to the designated manufacturing or packaging site.
Import, export, and/or destruct complaint samples following necessary procedures.
Maintain complaint products and lab supplies.
Conduct cleaning and maintenance of laboratory and equipment.

Assessment

Assess product complaint information, including designating an appropriate complaint level and assigning suitable categories.
Determine the need for additional investigation and forward product complaint records to the proper manufacturing or packaging quality unit as required.
Determine the need for investigation of the product complaint sample.

Common

Build and maintain working relationships and influence outcomes with manufacturing/packaging sites to deliver complaint investigations timely.
Perform follow-up activities with affiliates or related contacts, as necessary, to obtain additional details associated with product complaint information or returned complaint samples.
Evaluate the completed complaint investigation result and identify possible root causes of the product complaint.
Where additional information may aid in determining the root cause of the product complaint, obtain supplementary information from related parties.
Respond to affiliates or related contacts with educational information, as applicable, during follow-up endeavors.
Document assessment and analysis results in the complaint database and associated records.
Review and evaluate the records for completeness and compliance with Global Quality Standards.
Work effectively and efficiently as a team to deliver results in a defined timeline and to manage the operation.
Serve as a subject matter expert (SME) for applicable systems and procedures/work instructions, and for instructors.
Participate in supporting/supplemental activities, improvement activities, and oversight/monitoring activities.
Comply with Lilly Global/Local Quality System in addition to Global/Local regulations.
Maintain related IT systems.

Required Experience/Skills/Qualifications

A bachelor’s degree or above in a science-related field (e.g., pharmacy, chemistry, biology, engineering).
Experience in manufacturing or quality divisions in a manufacturing industry such as pharmaceutical, chemical, consumer goods, cosmetics, or food company (1 year or more).
Japanese and English communication skills (e.g., Versant score: 47, TOEIC score: 730, or equivalent).
For employee well-being and productivity, the commuting distance from home to the workplace is within 90km, and the travel time by public transportation via the cheapest route is within 90 minutes. If you live further away, you are generally required to relocate to within commuting distance (company-leased housing available). This also applies if vehicle commuting is permitted.

Desired Experience/Skills/Qualifications

Experience involved in drugs, medical devices, or in-vitro diagnostics at work.
Experience communicating in English at work with overseas contacts.

Compensation & Benefits

Salary: Preferential treatment according to company regulations.
Allowances: Housing allowance, commuting expenses, etc.
Salary Increase: Yes.
Bonus: Performance-based variable bonus paid based on individual and company performance. Sales positions receive bonuses in September and March of the following year; non-sales positions receive bonuses in March of the following year.
Working Hours: 8:45 - 17:30.
Overtime Pay: Only for "Associate" positions.
Discretionary Work System: Applicable. Flexible time: 5:00 - 22:00 (excluding collective break). Minimum required working hours per day: 4 hours (2 hours for half-day leave). Collective break: 12:00 - 13:00.
Remote Work System: Yes.
Smoking Policy: Entire workplace is non-smoking.
Holidays: Complete two-day weekend (Saturday and Sunday), national holidays, Christmas, New Year's holidays, summer holidays.
*Annual holidays: 125 days, annual paid leave, congratulatory/condolence leave, etc.
Insurance: Employment, Workers' Accident Compensation, Health, Employees' Pension Insurance.
Welfare: Housing assistance system, company-leased housing system, Lilly Group compensation system (medical and dental expense subsidies, etc.).
Retirement Age: Yes (60 years old).
Continued Employment System: Yes (up to 65 years old).
Paid Leave: Annual paid leave for employees who join mid-year is granted on the 1st of the month following their joining month, according to the following entry month categories. Regardless of the joining date, the employment period is considered to have passed one year as of December 31st of that year, and annual paid leave for the next year is granted on January 1st of the following year.
Joining Month: 1-6 months, 7 months, 8 months, 9 months, 10 months, 11 months, 12 months
Days Granted: 10, 5, 4, 3, 2, 1, 0
Probationary Period: 6 months. There is no difference in wages during the probationary period.