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Quality Analyst II

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Job ID R0043335 Date posted Aug. 19, 2021 Location Thousand Oaks, California

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as aQuality Analyst II in our Thousand Oaks, CAoffice.

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 deliverBetter Health and a Brighter Futureto people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

The Quality Analyst II will be responsible for performing the day-to-day quality operations for QA Release Department within the Quality organization.  They must identify and assess quality risks in activities and processes according to regulatory agency rules and guidelines and Takeda quality practices.

Essential Duties and Responsibilities

  • Responsible for reviewing pertinent documents, against Standard Operating Procedures (SOPs) for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc.
  • Identify areas of nonconformance and inform management via the drafting of Deviations as needed to be disposed (unilaterally accepted or rejected) by others.
  • Conduct, perform, and/or review investigations for non-conformances within respective area. Investigational activities include description of event, root cause analysis, product impact, corrections, corrective action and/or preventive action. Assist in identifying corrective actions in order to prevent recurring non-conformances.
  • Administer and maintain relevant databases, preparing and issuing reports as defined by the area as well as developing custom reports as needed.
  • Assist in external and internal audits/inspections by maintaining audit records, extracting data from databases, and creating reports, collecting relevant data, etc.  Support process with timely closure of observations/audit items.
  • Serve as a team member and/or assist in CAPA Investigations for significant issues within respective area.
  • Maintain and update departmental business indicators.
  • Prepare metrics for the Management Review of Quality Systems.
  • Audit/review documents as needed for completeness, CGMP’s, company procedures and verification of data. Correct any deficiencies found.
  • Assist and/or prepare Annual Product Review (APR) for products as directed.
  • Write Technical reports (e.g.PQR and YBPR)
  • Assist in the development, review, and revision of SOPs in support of Division Procedure Compliance and continuous improvement efforts as needed.
  • Assist in training Quality team members
  • May perform other duties as assigned.

Qualifications

  • Strong interpersonal skills and great attention to detail are necessary.
  • Strong team player with effective communication skills and able to handle multiple projects concurrently
  • Able to apply problem solving tools and methods to coordinate and/or lead investigation teams.
  • Good understanding of Current Good Manufacturing Practices (CGMP) as well as Good Documentation Practices (GDP).
  • Knowledge of FDA regulations, Application of Good Laboratory Practices and Application of Good Manufacturing Practices
  • Experience with Microsoft Excel, Word, and PowerPoint.

Education and/or experience

  • High school diploma or equivalent required.
  • Bachelor’s degree in a scientific discipline preferred.
  • Minimum of 3 to 5 years of related work experience.

Physical Demand

  • The overall physical exertion of this position is sedentary.
  • The duty of performing tagging or transfer of frozen BDS may require lifting and carrying of up to 10 lbs., occasionally standing or walking and overhead reaching into freezer compartments.
  • Batch record Review on the Floor (BRR) may require being on your feet for long periods of time.

Working Environment

  • Normal office environment.
  • This position may require overtime, weekend, and holiday work. 
  • May be assigned to a different shift as needed.
  • May be required to travel for business reasons, e.g. training and meetings.
  • Must be able to work in controlled or clean room environments requiring special gowning. Will be required to 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 these work environments.
  • May work in a cold, wet environment, or cool/hot storage conditions; may be exposed to sunlight, heat, dust, gases, and fumes
  • May climb up and into large processing tanks for cleaning or inspection.
  • May be working in a loud area that requires hearing protection and other protective equipment to be worn.
  • May work around chemicals such as alcohol, acids, buffers and celite that may require respiratory protection.
  • May be required to work in a confined area as defined by the Environmental, Health, & Safety office.
  • May be required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes.
  • May require immunization before performing work within the manufacturing area.
  • This job posting excludes CO applicants.

EEO Verbiage for US Reqs

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 - Thousand Oaks - Rancho Conejo

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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