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Job Description

Job Title: Quality Control Analyst

Location: Thousand Oaks, CA

About the role:

You will report to the QC Microbiology Manager. In the QC Microbiology department, the primary responsibilities of the Quality Control Analyst I is to conduct biological or chemical analyses on raw materials, in-process samples, final product samples and the collection of environmental monitoring programs at Takeda manufacturing facilities.

How you will contribute:

• Use laboratory instrumentation including analytical equipment, autoclaves, and incubators.
• Perform assays requiring precise analytical skills and understanding of biology and chemistry principles.
• Conduct biological, chemical, and physical analyses on raw materials, initial, in-process and final products, and samples collected from environmental monitoring.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and CGMP regulations.
• Investigate nonconformances and write exception documents.
• Participate in functions involving teams, which impact production, increase efficiency,, create cost savings, and improve quality.
• 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 as required. Audit and update, as required, plant SOPs.
• Perform test equipment, equipment maintenance and calibrations as required.
• General knowledge of FDA regulations, application of Good Laboratory Practices, application of Good Manufacturing Practices and application of Good Documentation Practices.
• General understanding & knowledge of the following areas:
  • Basic 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 (preferred)
• Proficient in a variety of to use statistical tools is preferred.

Minimum Requirements/Qualifications:

• Bachelor’s degree in microbiology or Biological Sciences (with Microbiology Laboratory) is strongly preferred.
• Minimum 1 year of related experience preferred.
• Experience in quality operations, biotechnology, pharmaceutical or similar GMP manufacturing environment is preferred, but not required.

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.

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/power grasping and pushing/pulling with hands/arms between 3-4 hours.
• May require fine manipulation up to 1 hour.
• May be required to gown frequently and balance when gowning into clean areas.
• May experience 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, dust, gases, chemicals, liquid Nitrogen, and fumes.
• 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, respiratory, or auditory protective equipment.
• May be required to work with biohazards such as: bloodborne pathogens, sewage, or medical waste.
• 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.
• 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 respiratory protection.
• May be required to manage hazardous waste 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 work around Methotrexate, which is a known cell growth inhibitor.
• May require immunization before performing work within the manufacturing area.
• May require overtime, weekend, and holiday work.   
• May be required to work or be assigned to a different shift as needed.

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.

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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.

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