Quality Control Analyst Ii

2 weeks ago


Thousand Oaks, California, United States ARIAD Full time
At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization.

It's reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network.

When you're a part of our team, you'll do meaningful work that makes an impact on the lives of patients.

Learn more about us and explore the opportunities to build a remarkable career.

Job ID R0123664
Date posted 05/23/2024
Location Thousand Oaks, California

Job Title:
Quality Control Analyst II

Location:
Thousand Oaks, CA

About the role:


As a QC Analyst II, you will conduct 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 HPLC Lab Supervisor.

How you will contribute:

  • Conduct biological, chemical, and physical analyses on raw materials, initial, inprocess 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 Laboratory Information Management System or other computerized systems.
  • May prepare monthly quality trend reports.
  • Perform laboratory audits and updates, plant SOPs.
  • Perform test equipment, equipment maintenance and calibrations.
  • Laboratory functions, test methods, equipment (including but not limited to 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 troubleshoot procedures for lab equipment
  • Knowledge of quality and regulatory requirements important to pharmaceutical manufacturing labs would be ideal.

What you bring to Takeda:

  • High School degree or equivalent required; Bachelor's Degree in Chemistry, Microbiology or Biological Sciences would be ideal.
  • Minimum 2 years of related work experience.
  • Experience in quality operations, biotechnology, pharmaceutical or similar GMP manufacturing environment would be ideal.

Important Considerations:

At 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.


In this role, you may:

  • The overall physical exertion of this position requires light to medium work.
  • May be required to sit between 34 hours, walk between 12 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 12 hours.
  • May be required to reach above/below the shoulder, kneel, twist at the neck/waist between 12 hours.
  • May be required to lift up to 50lbs between 510lbs up to 30x per shift, 1125lbs up to 5x per shift, and 2650lbs up to 5x per shift.
  • May be required to carry 510lbs up to 30x per shift up to 20ft, 1125lbs up to 5x per shift up to 5ft, and 2650lbs 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 34 hours.
  • May require fine manipulation up to 1 hour.
  • May require pushing/pulling with hands/arms between 34 hours.
  • May require office work activities with hands/arms between 34 hours in all Quality areas.
  • May be exposed to 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 be exposed to dust, gases, chemicals, liquid Nitrogen, and fumes (may require respiratory protection).
  • May be required to work at heights above floor level.
  • Will not be required to operate foot controls or repetitive foot movement.
  • May require the use of special visual or auditory protective equipment.
  • May be required to work with biohazards such as: bloodborne pathogens, sewage, or medical waste in all Quality areas.
  • May be required to work in confined areas.
  • Laboratory environment; inside working conditions
  • Must wear personal protective equipment due to safety requirements in designated lab areas.
  • May 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.
  • Will need to remove all makeup, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
  • May work around chemicals such as alcohol, acids, buffers and Celite that may require


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