Quality Analyst 1

Posted 21 Nov 2019

Carlsbad, California - United States

Req Id 200365

Details

A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.


Your Role:

As a Quality Analyst 1, you will support the comprehensive quality metrics, including entering, tracking and trending EM data, managing timelines and working with various stakeholders to successfully deliver customer deliverables, while helping to maintain our production environment in a state of readiness.  

 

Physical Attributes:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties, the employee is:

Constantly required to sit and reach to use computers and other office/lab equipment

Occasionally stand for extended periods of time, up to four (4) to five (5) hours/time

Occasionally required to lift up to fifty (50) pounds

Constantly required to view objects at close and distant ranges

Frequently required to communicate with others

Employee frequently works in a professional office environment and lab with computer equipment, machinery, tools, and moderate amounts of noise and activity. Employee may occasionally be exposed to fumes, airborne particles, chemicals, vibration and biohazardous materials. The work environment is fast-paced and demanding. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct off- shift, weekend, and overtime duties may be required as assigned by the manager of the employee.

 

Who you are:

Basic Qualifications:

  • Highschool Diploma OR GED required. Bachelor’s in science disciple highly preferred
  • 2+ years of experience in Quality Control OR CMO environment.
  • 1+ years’ experience with cGMP, aseptic techniques, microbiology testing, Environmental Monitoring, automation, troubleshooting for machineries, equipment, software and data integrity.
  • 1+ years’ experience in Lean Manufacturing and Continuous Improvement.

 

Preferred Qualifications:

  • Previous experience in quality systems supporting ISO 9001 and 134585 certifications as well as FDA regulations (such as 21CFR11) highly preferred.
  • Previous experience with governmental regulatory guidelines relating to the manufacturing of biologics and pharmaceuticals as well as compendial methods highly preferred
  • Excellent technical expertise in Microbiology and Environmental Monitoring fields.
  • Previous experience of utilizing and/ implementing electronic Microbiology/EM software (MODA or Novatek or equivalent) is required.
  • Working knowledge of validations, calibration systems, process design, design of experiment, instrumentation, automation, and digitization/paperless system.
  • Operational knowledge of the regulation (cGMP, ISO, EMA) and directives, and liability for non-compliance.
  • Ability to analyze past and current data and recommend objectives to improve productivity and increase efficiency.
  • Working knowledge of method development, qualification and validation and method transfer principals

RSRMS


What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com


The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

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