Lead Quality Assurance Technician at Baxalta U.S., Inc. in Los Angeles, California

Job Description:

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Job Description

About the role:

Join Takeda as a Lead QA Technician where you will perform all primary Quality Assurance activities for Teardown/ Fractionation or Purification, which includes providing daily quality on the shop floor oversight: manufacturing batch record and documentation review for accuracy and compliance to procedure. As part of the Quality Assurance team, you will report to the Supervisor, Quality Assurance.

**SCHELDULE: 2nd Shift (2:00 PM to 10:30 PM)

How you'll make an impact:

• Assure compliance with cGMP, GDDP and support internal and external audits
  
  


• Review and release batch records and associated documents against Standard Operating Procedures and internal guidelines as assigned
  
  


• Perform scheduled and unscheduled walkthroughs of Manufacturing, facilities and supporting areas for verification of acceptable cGMP Facility and equipment conditions and resolution of actions.
  
  


• Interpret and evaluate issues for acceptability to standards, procedures and regulatory requirements. Obtain resolution on issues identified as non-conformance. Provide guidance on documentation of issues with immediate corrections and corrective actions
  
  


• Perform initial investigations and reviews Deviations, CAPAs, and User Interventions
  
  


• Identify areas for improvements to reduce recurring non-conformances and drive continuous improvement
  
  


• Work with change owners to ensure change packages are accurate and meet requirements set forth
  
  


• Develop and lead project(s) as assigned by management
  
  


• Administer and maintain relevant databases, prepare and issue reports as defined by the area
  
  


• Support internal self-inspections and external audits by collecting and reviewing documents
  
  


• Provide guidance and training to employees within the department and member of other departments
  
  

• Knowledge of Regulations, Application of Good Data and Documentation Practices (GDDP) and application of current Good Manufacturing Practices (cGMP)
  
  


• Knowledge of biopharmaceutical/ biotech manufacturing theories and processes
  
  


• Good investigational experience: see the actual process on the floor (GEMBA) where issue occurred and recommend immediate corrections actions
  
  


• Use DeltaV system and EBM to analyze trending
  
  


• Ability to generate spreadsheets (can maintain complex spreadsheets) and prepare reports and PowerPoint presentations
  
  


• Yellow Belt/ Green Belt training/certification preferred
  
  


• Typically requires a Bachelor's degree in science, engineering or other related technical field
  
  


• 2+ years of related experience
  
  


• May work in controlled and confined environments requiring special gowning
  
  


• No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn
  
  


• Will work in a cold, wet environment
  
  

• 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
  
  


• Paid time off for vacation, sick leave, specific holidays, and volunteering
  
  


• Family Planning Support
  
  


• Professional development opportunities
  
  


• Tuition reimbursement
  
  

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and outstanding patient support programs. Takeda is a patient-focused company that inspires and empowers you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.

This posting excludes Colorado applicants

#GMSGQ

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