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Quality Control Analyst Ii

1 month ago

Thousand Oaks, 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, CaliforniaJob 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, 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 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 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 be required to 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 be required to 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 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 make-up, 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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