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Quality Control Analyst II

Company: Takeda Pharmaceutical
Location: Moorpark
Posted on: September 25, 2022

Job Description:

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionJob Title: Quality Control Analyst IILocation: Thousand Oaks, CAAbout the role:The QC Analyst II conducts biological or chemical and physical analyses on raw materials, in-process samples, final product samples and other samples collected from manufacturing areas. You will report to the MI&S Supervisor.How you will contribute:

  • Conduct biological, chemical, and physical analyses on raw materials, initial, in-process and final products, and samples collected from environmental monitoring.
  • Investigate nonconformances and write exception documents.
  • Handle multiple tasks concurrently including testing, special project / protocol testing.
  • Perform review of test data, which includes overall documentation practices (CGDP). Perform release functions in LIMS or other computerized systems.
  • May prepare monthly quality trend reports.
  • Perform laboratory audits. Audit and update plant SOPs.
  • Perform test equipment, equipment maintenance and calibrations.
  • Experience with the following areas:
    • Laboratory functions, test methods, equipment including analytical equipment, autoclaves, incubators, and environmental monitoring equipment, processes and applicable procedures.
    • Laboratory safety including standard precautions and hazardous and biohazardous chemical handling.
    • Wet and instrumental methods of analyses.
    • Operate and troubleshooting procedures for lab equipment
    • General knowledge of FDA regulations, application of Good Laboratory Practices, application of Good Manufacturing Practices and application of Good Documentation Practices.
    • Knowledge of quality and regulatory requirements appropriate to pharmaceutical manufacturing labs.
    • You will write detailed investigation reports, knowledge of how to implement investigation strategies and apply cause failure analysis.
    • You will work on multiple workflows and meet established timelines.
    • Strong decision-making skills, technical problem-solving ability, and analytical skills.What you bring to Takeda:
      • High School degree or equivalent required; Bachelor's Degree in Chemistry, Microbiology or Biological Sciences
      • Minimum 2 years of related work experience.
      • Experience in quality operations, biotechnology, pharmaceutical or similar GMP manufacturing environment.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 development opportunities
        • Tuition reimbursementImportant ConsiderationsAt Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. You may:
          • The physical exertion of this role is light to medium work.
          • May be required to sit between 3-4 hours, walk between 1-2 hours and stand for over 4 hours
          • May be required to bend at the neck/waist, squat and climb (using step stools and ladders) between 1-2 hours
          • May be required to reach above/below the shoulder, kneel, twist at the neck/waist between 1-2 hours
          • May lift up to 50lbs between 5-10lbs up to 30x per shift, 11-25lbs up to 5x per shift, and 26-50lbs up to 5x per shift
          • May carry 5-10lbs up to 30x per shift up to 20ft, 11-25lbs up to 5x per shift up to 5ft, and 26-50lbs up to 5x per shift up to 5ft
          • Requires repetitive use of both right and left hands over 4 hours
          • May require simple and power grasping between 3-4 hours
          • May require fine manipulation up to 1 hour
          • May require pushing/pulling with hands/arms between 3-4 hours
          • May require office work activities with hands/arms between 3-4 hours in all Quality areas
          • May be required to gown frequently and balance when gowning into clean areas
          • May work with noise above 85 dBA. This may require hearing protection and other protective equipment to be worn.
          • May work and have exposure to hot, cold, wet environment/conditions.
          • May work with dust, gasses, chemicals, liquid Nitrogen, and fumes (may require respiratory protection)
          • May work at heights above floor level
          • Will not operate foot controls or repetitive foot movement
          • May require the use of special visual or auditory protective equipment
          • May work with biohazards such as: bloodborne pathogens, sewage or medical waste in all Quality areas.
          • May work in confined areas.
          • Laboratory environment; inside working conditions
          • Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
          • Need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.
          • Work in a hot, cold, or wet environment.
          • Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
          • May manage hazardous wastes in compliance with company procedures and State/Federal/Local hazardous waste regulations. Tasks may include identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes.
          • May work around Methotrexate, which is a known cell growth inhibitor.
          • May require immunization before performing work within the manufacturing area.
          • Overtime may be required.
          • Will work an alternate work schedule (10-hour shift / 4 days a week).
          • May work or be assigned to a different shift.
          • Maybe required to work weekends and holidays.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.This posting excludes Colorado applicants.#GMSGQ#ZR1EEO StatementTakeda 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.LocationsUSA - CA - Thousand Oaks - Rancho ConejoWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeby Jobble

Keywords: Takeda Pharmaceutical, Los Angeles , Quality Control Analyst II, Professions , Moorpark, California

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