Fresenius Medical Care

Operates dialysis facilities and renal care

Quality Control Specialist 2

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeBuzen, Fukuoka, JapanNo salary listedIn-person

About the Job

Requirements

Ability to read, write, and communicate in both Japanese and English at above daily-conversation level.

Responsibilities

Lead the chemical-testing team and manage testing operations.
Check submitted test datasheets and submit them to the quality responsible person.
Investigate root causes, create nonconformance/corrective and preventive action documentation when necessary, and report quality issues to the quality responsible person.
Lead validation activities related to chemical tests, including test methods and CIP, by preparing protocols, executing tests, collecting data, and reporting results.
Create and maintain standard operating procedures and documentation mainly required for chemical tests.
Manage test schedules and the work schedules of the chemical-testing team.
Perform product release testing, including appearance; identification tests for glucose, lactate, chloride, sodium, calcium, and magnesium; pH; aluminum; 5-HMF; hydrogen carbonate; visible and sub-visible particulate contamination; extractable volume; and assays for glucose, lactate, chloride, sodium, calcium, and magnesium.
Perform in-process mixing-solution tests on PD products, including measuring pH, chloride, sodium, lactate, magnesium, and calcium.
Perform incoming inspection tests of pharmaceutical ingredients, including identification, purity, and quantitative tests.
Perform quality tests of manufacturing water (WFI, PS, DIW, HPW, HPS, and PW), including TOC, conductivity, nitrates, and aluminum tests.
Perform quality tests on PD product parts, including verifying the barcode quality of APD connectors and testing plastic containers.
Make judgments on test reports in the absence of or on behalf of the quality responsible person.
Assess situations and instruct relevant departments in the absence of or on behalf of the quality responsible person.
Perform daily checks of testing equipment, confirm calibration status, arrange repairs as necessary, and manage quality-testing consumables.
Manage testing reagents by monitoring inventory and handling simple purchasing and replenishment activities.
When installing new test equipment or arranging replacements, prepare required documents such as CAPEX applications and quotations and submit them for approval.
Attend departmental and Environment, Health and Safety meetings to share information and exchange opinions related to assigned responsibilities.
Exchange necessary information with other sites through email, phone calls, Teams meetings, and face-to-face meetings.

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.

About the Company

Fresenius Medical Care

Operates dialysis facilities and renal care

Fresenius Medical Care North America provides renal care through a network of dialysis facilities and outpatient cardiac and vascular labs that deliver coordinated treatment for chronically ill patients. It also offers specialty pharmacy and laboratory services and manufactures and distributes dialysis equipment, disposables, and renal medicines. The company stands out by being the world’s largest fully integrated renal care provider with an extensive network that covers care delivery, drug and lab services, and product supply. Its goal is to ensure access to comprehensive, high-quality care for people with kidney and other chronic conditions across North America.

Company size: 11-50
Company stage: Late Stage VC
Total funding: $40.2M
Headquarters: Waltham, MA
Founded: 1996

Recently Posted Jobs

Explore more opportunities at Fresenius Medical Care

See more jobs