Quality Analyst 1, Microbiology

Posted 03 Sep 2020

Carlsbad, California - United States

Req Id 209810

Details

A career with MilliporeSigma is an ongoing journey of discovery: our 57,000 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 in the Quality Control Environmental Monitoring group, you will support the site by testing the quality of the cleanroom manufacturing environment. The cleanrooms at SAFC Carlsbad adhere to strict regulatory and ISO requirements. To ensure that the quality of the environment is being maintained, Environmental Monitoring technicians routinely test the quality and microbial load of the surfaces, HVAC, and water systems within the facility.

Monitoring activities include, but are not limited to, collecting surface, air, water and personnel samples, monitoring manufacturing processes, enumerating microbial plates, data entry, trend analysis, reporting deviations and nonconformances, and investigation support. The role will entail operating in a fast-paced, highly dynamic environment in collaboration with other departments as well as external stakeholders.

 

Who you are:

As a Quality Analyst 1, you will support the daily operations of the Environmental Monitoring Group. You will need to collect samples, process samples, complete documentation, enter data, and review data for Environmental monitoring. Additionally, you will:

  • Comply with company EH&S requirements. Promote a safety-first culture.
  • Ensure that all required documentation (raw data, testing records, and logbooks) are completed accurately per Standard Operating Procedures (SOPs) and entered in timely manner.
  • Perform basic maintenance, such as equipment setup and cleaning as well as stocking/inventory of materials and consumables.
  • Perform autoclave sterilization as needed.
  • Report deviations and nonconformances through the quality management system.
  • Support investigations into nonconformances and deviations.
  • Support SOP revision processes and other related documentation as needed.
  • Support the protocol execution for special studies and projects as needed.
  • Prioritize tasks to ensure that projects are completed by the assigned deadlines.
  • Support team building by participating in interviewing new talent.

Basics Qualifications

Education Level and Languages Required

  • BA/BS degree or higher in a Life Science discipline or equivalent.
  • High School Diploma or Associate Degree in a Life Science discipline plus a minimum of 1 year of relevant experience.

 

 

 

Professional Skills, Qualifications and Experience

  • Experience with word processing software such as Microsoft Word
  • Experience with data entry and graphing using Microsoft Excel
  • Coursework in Microbiology is preferred

 

Travel Requirements

None for daily tasks, except for off-site trainings as needed.

 

Physical Requirements (PPE, lifting)

 

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:

  • Required to don PPE when entering the cleanroom space. PPE includes, safety glasses, face masks, hoods, scrubs, sterile gowns, gloves, sleeves, and boot covers.
  • 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. The employee may be required to conduct off- shift, weekend, and overtime duties as assigned by the manager of the employee.

 

Preferred Qualifications:

  • Previous experience with cGMP, aseptic techniques, microbiology testing, automation, troubleshooting for equipment, software and data integrity
  • Good understanding and knowledge of governmental regulatory guidelines relating to the manufacturing of biologics and pharmaceuticals
  • Prior experience with Aseptic Technique and Gowning

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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