Quality Control Specialist II

Manage of chemical Testing

• Lead chemical testing team and managing the testing operations thereafter.

• Check contents of submitted test datasheets and submit to quality responsible.

• Conduct investigation of root cause, create NC/CAPA if necessary and report to quality responsible when quality issue occurs.

• Lead various validation activities related to chemical tests such as test method/CIP, etc, by making the protocols, executing tests, collecting data and reporting.

• Create and maintain SOP/DS which are mainly necessary for chemical tests.

• Manage test schedule and work schedule of chemical test team.

Product Testing

• Perform release testing, including Appearance, Identification tests (Glucose, Lactate, Chloride, Sodium, Calcium, Magnesium), pH, Aluminum, 5-HMF, Hydrogen Carbonate, Particulate contamination-visible particles・sub-visible particles, extractable volume, and Assay (Glucose, Lactate, Chloride, Sodium, Calcium, Magnesium).

• Perform mixing solution test to PD products as In-process testing, including measurement of pH, Chloride, Na, Lactate, Mg and Ca.

• Perform incoming inspection test of pharmaceutical ingredients, including ID test or Identification test, Purity tests and Quantitative tests.

• Perform quality test of manufacturing water (WFI, PS, DIW, HPW, HPS, PW), including TOC, Conductivity, Nitrates and Aluminum tests.

• Perform quality tests for PD product’s parts, including verification of barcode quality of  APD connector and plastic container test.

Assisting/supporting quality responsible and others

• Make judgement on test reports in absence or on behalf of quality responsible.

• Assess the situation and instruct to relevant department in absence or on behalf of quality responsible.

Equipment & Reagent Management

• Perform daily checks of testing equipment, confirm calibration status, arrange repairs as necessary, and manage consumables used for quality testing.

• Manage testing reagents by monitoring inventory levels and handling simple purchasing and replenishment activities.

• When installation of new test equipment or replacement is necessary, prepare necessary documents such as CAPEX application form and quotations, and submit for approvals.

Meetings / Collaboration

• Attend departmental meetings and Environment, Health and Safety (EHS)-related meetings to share information and exchange opinions related to assigned responsibilities.

• Exchange necessary information with other sites if necessary. It incudes e-mail exchange, phone call, Teams meeting and face-to-face meeting.

Language

Ability of reading/writing/communication by Japanese and English

In particular, ability more than daily conversation level is required on both English and Japanese.