Quality Control Investigator I at Baxalta U.S., Inc. in Los Angeles, California

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

About the role:

You will conduct Laboratory investigations, close deviations, support assignment of proper corrective actions, and facilitate implementation for Quality Control Laboratory under the direction of Compliance Management.

Perform calculation, data collection to support QC lab site, global CI programs, and management reviews. Lead and promote completion of Lean or Six Sigma improvement projects and responsible milestones, as assigned. You will report to the Senior Manager of the Quality Control Lab Logistics and Compliance.

How you will contribute:

• Perform review of test data with application of GDP.


• Use Global LIMS or other computerized systems for entering and approving test results.


• May conduct investigations and audits into Alert/OOL, OOR and OOS excursions.


• Investigate deviations and write exception documents, using problem-solving tools.


• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR, and cGMP regulations.


• Assist Compliance Supervisor/Manager in updating department metrics and report shift activities, as assigned.


• Perform/support invalid/valid Laboratory Investigation (LIs) closures and appropriate documentation.


• Perform/support with ownership, and leading of change controls in addition to lab assessments


• Build and respond to relevant gap assessments and cascades


• Represent QC in applicable Phase 2 (Deviation) investigations and site QWTs

What you bring to Takeda:

• Typically requires bachelors' degree in science, engineering, or other related technical field. Bachelor's Degree in Chemistry or Biological Science is preferred.


• Must be able to lift, push, pull and carry up to 25 lbs and push up to 50 lbs.


• Will follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.


• Will work in a loud area that requires hearing protection and other protective equipment to be worn. 20/20 near vision required (corrected vision is acceptable) Will work in a cold, wet environment.


• Can work in controlled environments and requiring special gowning.


• Will work around chemicals such as alcohol, acids, and alkaline that requires protective equipment


• May work or be assigned to a different shift as needed.


• Can work overtime as required.


• May work in a confined area. Inside and Outdoor working conditions. Perform removal of hazardous waste.


• Traveling not required

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Professional training and development opportunities Tuition reimbursement

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Location and Salary Information: This post excludes CO applicants

#GMSGQ #ZR1

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

USA - CA - Los Angeles

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time