Experis Gaithersburg, MD
- Expired: over a month ago. Applications are no longer accepted.
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)
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
Talent Acquisition Specialist
Phone - 414-666-8462 Ext - 7147
100 Manpower Place | Milwaukee, WI 53212
ExperisWhy 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.