Microbiology Quality Control Analyst

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Job Description

Microbiology Quality Control Analyst

Thousand Oaks, CA (Onsite)

About the role:

As Microbiology QC Analyst, you will work in the QC Microbiology Lab, being responsible for conducting 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 Microbiology QC Supervisor.

How you will contribute:

• Perform assays requiring precise analytical skills and understanding of biology and chemistry principles.

• Use laboratory instrumentation including analytical equipment, autoclaves, and incubators.

• 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.

• Work on multiple tasks concurrently including testing, special project / protocol testing in a timely and appropriate manner.

• 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 Laboratory Information Management System or other computerized systems.

• May prepare monthly quality trend reports.

• Perform laboratory audits and update, plant SOPs.

• Perform test equipment, equipment maintenance and calibrations.

What you bring to Takeda:

• 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 analysis.

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

• Prioritize multiple projects/workflows to meet established timelines.

• Proficient in many mathematical disciplines; including ability to use statistical tools.

• Bachelor's Degree in Microbiology or Biological Sciences (with Microbiology Laboratory)

• Minimum 1 year of related experience.

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

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:

• Laboratory environment; inside working conditions.

• Must wear personal protective equipment due to safety requirements in designated lab areas. May work in controlled or clean room environments requiring special gowning.

• May manage hazardous wastes 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.

• Required to work an alternate work schedule (10-hour shift / 4 days a week).

• May require overtime, weekend, and holiday work.

• May work or be assigned to a different shift.

• 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 gown frequently and balance when gowning into clean 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, dust, gases, chemicals, liquid Nitrogen, and fumes.

• May work at heights above floor level.

• Will not operate foot controls or repetitive foot movement.

• 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.

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.

This posting excludes Colorado applicants.

Base Salary Range: $44,800 to $64,000. 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.

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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