Associate I, QC Microbiology, Environmental Monitoring

6 days ago

Marlborough, United States Randstad Life Sciences US Full time

Immediate opportunity for a QC Microbiology Associate I to join a leading biotechnology and pharmaceutical company specializing in RNA therapeutics, located in Marlborough, MA.


In this role, you will play a key part in the commissioning and qualification of the company's new Marlborough facility. Responsibilities include performing routine environmental monitoring, critical utility sampling (WFI and gas), and gowning.


Shedule/Shift: 1st shift, Mon.-Fri.

Position Type: 6 mos. contract; extension in 6 mos. increments up to 18 mos.


Position Summary: In this role, you will perform routine environmental monitoring and critical utilities (water and process gasses) sampling of the GMP manufacturing facility. The Quality Control (QC) Associate l will also support microbiological testing for GMP QC raw materials, excipients, drug substance and finished product testing for mRNA products produced at company’s manufacturing facility. The Quality Control (QC) Associate may perform projects as assigned.


Essential Duties and Responsibilities:

  • Perform routine environmental monitoring and critical utility sampling activities.
  • Conduct analysis of water samples to include TOC, Conductivity, Bioburden, and Endotoxin.
  • Conduct process gasses testing for Total particulates, Viable Air, Hydrocarbons and Dewpoint.
  • Perform routine testing in support of manufacturing processes to include bioburden, sterility, endotoxin, culture purity and cell stock identity.
  • Prepare and ship contract laboratory testing samples including those intended for microbiological identification.
  • Perform general laboratory support activities including equipment maintenance and housekeeping.
  • May participate in equipment and method qualifications, validations, and method transfers.
  • Perform data entry utilizing good documentation practices.
  • Support initiation/closure of quality system records such as environmental monitoring excursion notifications and deviations.
  • Write/revise standard operating procedures.
  • Additional duties as may be assigned from time to time


Qualificiations:

  • Bachelor's degree (BA / BS) in STEM field, OR five (5) years Quality Control experience in a cGMP organization with a focus in Microbiology
  • A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
  • This position is site-based, requiring you to be onsite full-time. This position is not eligible for remote work.


Preferred Skills and Experience:

  • Experience in a GMP QC laboratory setting, focusing on microbiology.
  • Hands-on experience with particle counters, viable air samplers, and gas equipment.
  • Proficiency with Microsoft Office Programs and electronic databases (LIMS, SAP, eQMS).
  • Excellent troubleshooting skills and the ability to communicate scientific issues clearly.
  • Strong written and oral communication skills and organizational abilities.
  • Knowledge of GMP, microbiology, aseptic techniques, and general laboratory instrumentation.
  • Ability to work effectively in a fast-paced, cross-functional matrix environment.
  • Familiarity with relevant FDA, EU, ICH guidelines, and regulations.

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