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Job Description

Location: Thousand Oaks, CA

About the role:

As the Quality Control Analyst in the QC Microbiology Lab, 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.

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 nonconformance's and write exception documents.

• Complete multiple tasks concurrently including testing, special project / protocol testing.

• Participate in functions involving teams, which impact production, increase efficiency, generate 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. Audit 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.

What you bring to Takeda:

• 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 would be ideal

• General knowledge of FDA regulations, application of Good Laboratory Practices, application of Good Manufacturing Practices and application of Good Documentation Practices is preferred.

• Wet and instrumental methods of analyses (preferred).

• Can work in a team environment.

• Can work on multiple projects/workflows to meet established timelines.

• Has technical problem-solving ability and analytical skills.

• Proficient in multiple mathematical disciplines; including the use statistical tools would be helpful

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 training and development opportunities

• Tuition reimbursement

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:

• 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 (Noise above 85 dBA).

• Need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.

• Work in a cold, wet environment.

• Work multiple shifts, including weekends, or be asked to work supplemental hours.

• Work around chemicals such as alcohol, acids, buffers, Celite, and Methotrexate, which is a known cell growth inhibitor that may require respiratory protection.

• Can sit between 3-4 hours, walk between 1-2 hours and stand for over 4 hours.

• Can bend at the neck/waist, squat and climb (using step stools and ladders) between 1-2 hours.

• Can reach above/below the shoulder, kneel, twist at the neck/waist between 1-2 hours.

• Can 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.

• Can 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.

• Will not operate foot controls or repetitive foot movement and work at heights above floor level

• May require the use of special visual, respiratory, or auditory protective equipment.

• May work with biohazards such as: bloodborne pathogens, sewage, or medical waste.

• May work in confined areas.

• Laboratory environment; inside working conditions.

• May manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Responsibilities may include identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes.

• May require immunization before performing work within the manufacturing area

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.

Base Salary Range: $44,800.00 to $ 64,000.00. Employees may also be eligible for Short-term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program, and Paid Volunteer Time Off. The final salary offered for this position may take into account a number of factors, including, but not limited to, location, skills, education, and experience.

#GMSGQ #ZR1 #LI-1

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.

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