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QC Analyst

Experis Gaithersburg, MD

  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Hi,

This is Hershita working as Recruitment Specialist with Experis part of Manpower Group. Please have a look at the job description and if you are interested, please reply back with an updated copy of your Resume. Please send your updated resume to () and I will be happy to have this moving swiftly.

Job Role: QC Analyst

Location: Gaithersburg MD 20878

Duration: 6+ Months. (Possibility of Extension)

Job Description:

This role is responsible for Environmental Monitoring sampling, analyzing, and aseptic monitoring and microbiological testing to support Phase I/II GMP manufacturing. Works in a fast-paced environmental supporting the quality control department of a CMO for manufacturing of biologic bulk drug substance, sterile finished drug product, and fill/finish.

Key Responsibilities include but are not limited to:

  • Primary responsibility is in Environmental Monitoring in classified cleanrooms. Monitoring of surfaces, air, and non-viable air quality of ISO 5, 7, and 8 cleanrooms.
  • Conducts testing of utilities such as USP water, clean steam, and testing of other manufacturing environments (air, surfaces)
  • Builds credibility within the lab group by performing high quality work
  • Works closely with manufacturing and QA to coordinate routine EM, changeover EM, and monitoring to support client campaigns
  • Performs media fills and fill/finish monitoring which includes continuous monitoring of air quality, personnel aseptic technique, and environment integrity
  • Acts as Quality Control authority for aseptic flow and behavior within cleanrooms
  • Utilizes MODA to enter, compile, and trend environmental data for reporting purposes
  • Works closely with Manufacturing and Quality Assurance staff to resolve quality issues with regard to the facility
  • Effectively communicates results of own work through discussions and documentation with some input from supervisor
  • Flexibility in following unique campaign requirements that may include off-hour and weekend work
  • May conduct bioburden and membrane filtration testing on cleaning, in-process and release samples.

Experience & Education:

  • Associates degree in a Life Sciences discipline and 2 years of relevant experience working in cGMP cleanrooms
  • Experience working in cGMP Quality Control
  • Experience with Microsoft Excel and Microsoft Word
  • Strong attention to detail
  • Familiarity with Good Manufacturing Practices (cGMP's)
  • Have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
  • Must be able to work off hours or weekends as required
  • LIMS or MODA experience a plus
  • Experience conducting bioburden and membrane filtration testing a plus


Thanks

Hershita Singhal

Talent Acquisition Specialist

Experis CORE+

Phone - 414-666-8462 Ext - 7147

100 Manpower Place | Milwaukee, WI 53212

Company Description
Experis is the global leader in professional resourcing and project-based solutions. Experis accelerates organizations' growth by attracting, assessing and placing specialized expertise in IT, Finance and Engineering to deliver in-demand talent for mission-critical positions and projects, enhancing the competitiveness of the organizations and people we serve. Experis is part of the ManpowerGroup® family of companies, which also includes Manpower and Talent Solutions.

Experis

Why Work Here?
Experis doesn’t just find you a job. We give you the power to create a career path, reach for new opportunities and achieve your goals.

Experis is the global leader in professional resourcing and project-based solutions. Experis accelerates organizations' growth by attracting, assessing and placing specialized expertise in IT, Finance and Engineering to deliver in-demand talent for mission-critical positions and projects, enhancing the competitiveness of the organizations and people we serve. Experis is part of the ManpowerGroup® family of companies, which also includes Manpower and Talent Solutions.

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Gaithersburg, MD
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