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Quality Assurance Analyst

2 months ago

Thousand Oaks, United States Randstad Full time

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.


Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Quality Assurance Analyst Receiving and Inspection at our Thousand Oaks, CA site. Here, you will be a vital contributor to our inspiring, bold mission.


Summary:

The Quality Analyst is responsible for performing the day-to-day quality operations for the Quality Assurance (QA) department, including batch record review on the floor and quality inspection activities associated with Formulation & Filling, Final Packaging and Device Assembly processes.


Title: QA Analyst I

Location: Fully onsite Thousand Oaks, CA

Duration: 6 months

Pay: $30-$40 (Very dependent on level and experience)


Responsibilities:

  • Responsible for QA Inspection activities associated with visual inspection, assembly, packaging, and label stores management.
  • Perform the final review of QA Inspection documentation to support Filled Unlabeled Vial (FUV) and Final Drug Product (FDP) release.
  • Identify and assess quality risks in activities and processes according to regulatory agency requirements and guidelines and Takeda quality practices.
  • Revise documents to drive continuous improvement including streamlining processes and maintaining GMP compliance.
  • Support departmental projects and any quality working teams when required.
  • Perform on the floor lot/batch documentation review to ensure compliance with all requirements.
  • Revise documents to support process improvements, corrective actions, corporate/division compliance, and audit commitments.
  • GEMBA participation – on the floor to see the process where events occur and implement robust corrective actions to correct root causes.
  • Able to prioritize and thrive in a fast-paced environment.
  • May perform other duties as assigned.


Qualifications:

  • Knowledge of biotech manufacturing theories and process is a must
  • Knowledge of FDA and EMA Regulations, Application of Good Documentation Practices (GDP), and application of current Good Manufacturing Practices (cGMP) is a plus.
  • Strong interpersonal skills, written/verbal skills, attention to detail and able to handle multiple tasks/projects concurrently.
  • Flexible and able to operate in a in a dynamic, cross-functional environment.
  • Strong organizational skills and the ability to plan, follow-up, and implement tasks.
  • Strong critical thinking and problem-solving skills (DMAIC, Six Sigma, and Lean experience preferred).
  • Skilled word processing, spreadsheet, project management, and presentation tools such as Microsoft Office (Word, Excel, Project, PowerPoint).
  • Able to communicate orally and in writing in a clear, concise understandable manner to supervisor and instruct co-employees.
  • Bachelor’s degree in science, engineering or another related technical field strongly preferred
  • 1+ years of related work experience preferred
  • Yellow Belt/Green Belt training/certification preferred