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Job Description
QUALITY ANALYST – QUALITY ASSURANCE SUPPORT
About the role:
Join Takeda as a Senior Quality Analyst where you will perform all primary quality assurance activities for the Quality Support team.
You will identify potential quality and compliance risks in activities and processes according to procedural requirements and Takeda Quality standards.
Provide assessments to support current regulatory requirements i.e., FDA, ISO, and Takeda Quality Systems, and serve as a plant resource for compliance to these requirements.
As part of the QA team, you will report directly to the Quality Assurance Supervisor and work with team members across Manufacturing, Engineering and Release & Inspection teams.
How you’ll make an impact:
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Partner with Quality Control, Critical Systems, Facilities, Manufacturing, Engineering, Warehouse and Release and Inspection (QARI) teams for Quality on the Shop Floor collaboration to ensure sound Quality decisions are made with compliance to standards and procedures
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Perform scheduled and unscheduled walkthroughs of QC, Manufacturing, Critical Systems, Facilities, and supporting areas for verification of acceptable cGMP facility and equipment conditions and resolution of actions
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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.
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Perform initial investigations and reviews deviations, CAPAs, and lab investigations
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Work with change owners to ensure change packages are accurate and meet requirements
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Administer and maintain relevant databases, prepare and issue reports as defined by the area
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Support internal self-inspections and external audits by collecting and reviewing documents
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Provide essential step verification guidance and training of employees within the department as assigned by management
What you bring to Takeda:
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Knowledge of Regulations, Application of Good Data and Documentation Practices (GDDP) and application of current Good Manufacturing Practices (cGMP)
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Knowledge of biopharmaceutical/ biotech manufacturing theories and processes
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Good investigational experience.
See the actual process on the floor (GEMBA) where issue occurred and recommend immediate corrections, and corrective actions for root cause
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Create spreadsheets (can maintain complex spreadsheets) and prepare reports and PowerPoint presentations
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Yellow Belt/ Green Belt training/certification (desired)
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Typically requires a Bachelor’s degree in science, engineering or other related technical field
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2 plus years of related experience
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Push, pull, and carry up to 25 lbs.
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In general, your work will be a combination of sedentary work, standing work, and walking around observing conditions in the facility
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Can work in controlled environments requiring special gowning (cold and wet)
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No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment
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May be asked to work in a confined area
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Some clean room and cool/hot storage conditions
What Takeda can offer you:
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Comprehensive Healthcare: Medical, Dental, and Vision
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Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
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Health & Wellness programs including onsite flu shots and health screenings
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Paid time off for vacation, sick leave, specific holidays, and volunteering
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Family Planning Support
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Professional development opportunities
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Tuition reimbursement
More about us:
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 will inspire and empower 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
USA
– CA
– Van Nuys
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time