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Quality Control Analyst II - Microbiology
A career with MilliporeSigma is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. 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.
We are offering a $7,500 sign-on bonus for those that qualify!
As a Quality Analyst II, you will support the comprehensive quality activities, including entering, tracking and trending Microbiology testing data, and managing timelines while ensuring the production environment is in a state of readiness for both testing and client audits. The role will entail operating in a fast-paced, highly dynamic environment with multifunctional groups/departments, including internal and external stakeholders. This role will support the daily operations of the Microbiology Lab and ensure that the Microbiology Lab is well maintained and supplied. It will complete documentation, data entry, data review, and trending for Microbiology testing data in a timely manner.
- Responsible for performing microbiological testing methods, but not limited to raw material testing and water testing
- Perform water sampling/testing, sterilization of equipment, growth promotion, endotoxin, microbial identification, biological indicator, and bioburden testing
- Ensure that required electronic data and documentation (raw data, testing records, and logbooks) are completed, reviewed, and trended accurately and entered in timely manner
- Perform simple compilation of data for tracking and trending
- Training of junior analysts to the QC Analyst/Microbiologist
- Initiate, investigate, resolve and complete event records within the controlled event system TRACKWISE
- Enter Microbial Identification data through to completion
- Operate and maintain lab equipment as required by SOPs and testing procedures
- Support SOP revision processes, Item Specification, and other related documentation
- Execute protocol and special studies as assigned
- Participate in protocol and final report preparation for special studies and projects as needed
- Act as potential resource of information for the junior analysts
- Able to distinguish potential issues and professionally suggest potential solutions
- Prioritize tasks to ensure that projects are completed by the assigned deadlines
- Support team building by participating in interviewing new talent
- Comply with company EH&S requirements
- Promote a safety-first culture
Who you are:
- High School Diploma or GED
- 2+ years of experience working in a cGMP regulated environment
- Bachelor’s Degree in Biology, Microbiology, Chemistry, or other life science discipline
- 1+ years of experience working in a cGMP regulated environment
- Experience with aseptic techniques, and microbiology testing
- Experience with electronic software TRACKWISE, LIMS or Novatek
- Previous knowledge/experience with Environmental Monitoring, automation, troubleshooting for machinery, equipment, and data integrity
- Understanding and knowledge of governmental regulatory guidelines relating to the manufacturing of biologics and pharmaceuticals
- Previous knowledge/experience with Aseptic Gowning
- Complete work independently and efficiently based on current SOPs and study protocol with minimal supervision
- Flexible and a team player
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!
Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html
If you are a resident of NYC, Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.
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.
As an employee of the Company, you will be required to comply with all of the Company’s COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.