Microbiology Quality Control Analyst - Thousand Oaks California

Company: Takeda
Location: Thousand Oaks, California
Posted On: 04/15/2024

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Job Description

Title: Microbiology Quality Control Analyst

Location: 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 nonconformance 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:
  
  
  • 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.
    
  • 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.
    
    
    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.
      
      #GMSGQ
      
      #ZR1
      
      #LI-CA
      
      #LI-Onsite
      
      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 e mployee s may be eligible for s hort - t erm 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 More...

          

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