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QC Microbiologist Associate (GMP)

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Date: Sep 18, 2021

Location: San Diego, CA, US

Company: Wacker Chemie AG

Our world needs ideas! As one of the world’s most research-intensive chemical companies, Wacker has been developing leading solutions for numerous sectors – from construction to photovoltaics and cosmetics to rubber – for over 100 years. We have a global presence with production sites on three continents and 13,800 employees from 70 nations.

Wacker Biotech, as part of Wacker, is a leading global biotechnology organization specializing in the production of biopharmaceuticals. The company has outstanding technologies for the rapid, efficient and thus cost-effective production of therapeutic proteins for clinical and commercial supply. Currently it is the biggest dedicated microbial Contract Development & Manufacturing Organization (CDMO) in the world. Its four dedicated and fast-growing production sites are currently based in Germany (Halle and Jena), The Netherlands (Amsterdam) and The United States (San Diego, CA).

Our regional presence in the U.S. is focused on GMP-compliant manufacturing of plasmid DNA products up to 500L. The team has extensive experience up to phase III clinical supply and successfully released more than 100 GMP batches for advanced therapy applications. 

At our San Diego site, we are currently looking for a ​QC Microbiologist Associate (GMP)​ to be a part of our growing team.

 

 

Job Responsibilities

 

We are currently seeking an Environmental Monitoring (EM) Associate to support Wacker manufacturing. The QC EM Associate will be a part of the Wacker Quality Control department to support routine environmental monitoring of the air, surface, and clean utilities of the production facility. As an Environmental Monitoring Associate, you will acquire an understanding of aseptic technique, continuously exhibit proper clean room behavior, and adhere to cGMPs.

  • Performs environmental monitoring within the microbiology laboratory, manufacturing suites, clean rooms, and drug product operations.
  • Performs enumeration and gram staining of bacterial colonies.
  • Documentation of results in accordance with current Good Manufacturing Practices (cGMP).
  • Sampling and analysis of the utilities including water, steam, and compressed gasses.
  • Support process qualification of water, HVAC, and other systems.
  • Must gown qualify and exemplify clean room behavior.
  • Maintains lab area including routine cleaning of benches, bio-safety cabinets, shelving, and floor.
  • Initiates routine environmental action level reports and deviation reports.
  • Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company policies and practices.

Qualifications

  • Bachelor’s degree preferred in a Life Sciences discipline or equivalent required
  • Minimum 2 years of experience working in laboratory or quality control is preferred.
  • Ability to perform testing in a highly accurate and reproducible manner.
  • Familiarity with cGMP, aseptic technique, manufacturing, machine operations, troubleshooting, and data entry.
  • Detail oriented with strong written and verbal communication skills.
  • Ability to work independently, within prescribed guidelines, or as a team member.
  • Demonstrated ability to follow detailed directions in a laboratory environment.
  • Must be familiar with Microsoft Office applications

 

WACKER, as an innovative chemical company, makes a vital contribution toward improving the quality of life around the world by developing intelligent solutions for sustainable growth. Our culture focuses on building and retaining diverse and inclusive teams. WACKER offers a great work environment, professional development, challenging careers, competitive benefit offerings and beyond through giving back to our communities.

 

Be part of our WACKER family, across all nations!

 

We are looking forward to your online application at www.wacker.com.
Reference Code: 6283 

 

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The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. A minimum requirement for this US-based position is the ability to work legally in the United States on a permanent unrestricted basis.  Visa sponsorship is not available for this position, including for any type of US permanent residency (e.g., for a Green card).

 

WACKER is proud to be an Equal Opportunity/Affirmative Action Employer, making decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected class.


Nearest Major Market: San Diego