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Lead QA Technician

応募後で応募 求人ID R0067701 掲載日 05/20/2022 Location:Los Angeles, California

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Job Description

About the role:

Perform all primary Quality Assurance activities for Teardown/ Fractionation (B5) or Purification (B8), which include providing daily Quality on the Shop Floor oversight: manufacturing batch record and documentation review for accuracy and compliance to procedure, Quality on the Shop Floor walkthroughs to assure cGMP compliance and resolution of issues, participating in trouble shooting and problem solving of manufacturing issues and supporting daily change control processes (insignificant changes and return to operations) observing FDA and Regulatory standards, ISO requirements and internal standard operating procedures.

Assure compliance with cGMP, GDDP and company procedures. Support internal and external audits. Identify potential Quality and compliance risks in activities and processes according to procedural requirements, 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. Uphold Takeda's Quality Culture elements of keeping it simple, taking pride in doing it right, ensuring a speak up culture and demonstrating commitment to Quality.

How you will contribute:

  • Partner up with Manufacturing for Quality on the Shop Floor collaboration to ensure sound Quality decisions are made with compliance to standards and procedures.

  • 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.

  • Work with manufacturing teams in functions that impact production, solve problems, improve quality, increase efficiency, create cost savings, and provide new product support.

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

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

  • Review and release batch records and associated documents against Standard Operating Procedure (SOPs) for accuracy and assure compliance to procedures based on regulatory requirements and internal guidelines.

  • 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 as assigned by management.

  • Provide guidance and training of employees within the department as assigned by management.

  • Provide guidance to members of other departments with regards to important step verification.

  • Support activities for other departments as assigned by management

What you bring to Takeda:

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

  • General 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 and corrective actions for root cause and corrective action (RCCA).

  • Have good critical thinking and problem-solving skills (DMAIC and Lean).

  • Be able to perform and analyze trending using DeltaV system and/or EBM.

  • Excel (spreadsheets) and PowerPoint (presentation) skills.

  • Be able to support departmental / plant goals.

  • Review and approve investigations.

  • Yellow Belt/ Green Belt training/certification.

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

  • 2+ years of related experience.

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

  • In general, you will have a combination of sedentary work and walking around observing conditions in the cGMP facility

  • Will work in controlled environments requiring special gowning. 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 cold, wet environment

  • Multiple shifts including weekends, is required.

  • Will work periodic overtime.

  • May work in a confined area.

  • Some clean room and cool/hot storage conditions.

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

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that 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 deliver Better Health and a Brighter Future to people around the world.

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
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