Quality Control Analyst

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Job Description

Job Title: Quality Control Analyst

Location: Thousand Oaks, CA

About the role:

As a Quality Control Analyst, you will work in the QC Microbiology Lab and 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 QC Microbiology Supervisor.

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 non-conformances and write exception documents.

• Handle testing, special project / protocol testing..

• 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 Laboratory Information Management Systems or other computerized systems.

• May prepare monthly quality trend reports.

• Perform laboratory audits and update, plant SOPs.

• Perform test equipment, equipment maintenance and calibrations.

• Basic 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 would be ideal.

• General knowledge of FDA regulations, application of Good Laboratory Practices, application of Good Manufacturing Practices and application of Good Documentation Practices would be ideal.

What you bring to Takeda:

• Bachelor's Degree in Microbiology or Biological Sciences (with Microbiology Laboratory) would be ideal.

• Minimum 1 year of related experience would be ideal.

• Experience in quality operations, biotechnology, pharmaceutical or similar GMP manufacturing environment would be idea.

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 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

• 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 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 in a cold, hot or wet environment.

• May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

• 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.

#GMSGQ

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Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

USA - CA - Thousand Oaks - Rancho Conejo

U.S. Hourly Wage Range:

$22.55 - $35.43

The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

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