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QC Associate

ICONMA, LLC

Kennard Corner, WA

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JOB DETAILS
SALARY
$20–$25.50 Per Hour
JOB TYPE
Temporary, Contractor, Full-time
SKILLS
Asepsis, Biology, Cleanroom, Data Entry, Detail Oriented, Documentation, Environmental Monitoring, GMP (Good Manufacturing Practices), Health Plan, Internal Audit, Inventory Management, Laboratory, Labware, Lead Generation, Lift/Move 25 Pounds, Manufacturing, Microbiology, Quality Control, Specimens/Samples, Test Lab, Training Program, Trend Analysis
LOCATION
Kennard Corner, WA
POSTED
26 days ago
Our Client, a Clinical-Stage Cell Therapy company, is looking for a QC Associate for their Bothell, WA  location.
 
Responsibilities:
  • Perform routine environmental monitoring of classified manufacturing areas including Grade A to Grade D cleanrooms.
  • Conduct viable and non-viable monitoring using:
    • Active air sampling
    • Surface contact plates
    • Particle counters
  • Perform personnel gowning qualifications.
  • Support cleanroom requalification and special monitoring activities as required.
  • Support Aseptic Processing Simulations (APS) and Aseptic Technique Qualification (ATQ) operations.
  • Ensure proper labeling, incubation, and documentation of EM samples.
  • Initiate and lead excursion investigations.
  • Assist with trend reports and data entry for environmental monitoring results.
  • Participate in internal audits, inspections, and training programs.
  • Maintain accurate sample inventory and chain-of-custody records in electronic systems.
  • Receive, log, track, and store incoming GMP samples from manufacturing, stability programs, and external sources. Use of an electronic system such as LabVantage or LabWare is a plus.
  • Distribute samples to QC laboratories for testing.
  • Support cleanroom and testing laboratories readiness activities including inventory management.
  • Coordinate sample shipment to external testing laboratories when required.
  • Support deviations, investigations, and CAPAs related to EM or sample management.
  • Complete documentation in accordance with Good Documentation Practices (GDP) and GMP regulations.
 
Requirements:
  • Bachelor’s degree in biology, Microbiology or related science field or equivalent experience
  • 2 years of laboratory or GMP experience
  • Basic understanding of environmental monitoring concepts
  • Strong attention to detail and documentation accuracy.
  • Ability to work in cleanroom environments and gown in full aseptic gowning (cleanroom gowning including masks, gloves, and coveralls) for extended periods.
  • Ability to work flexible hours including weekends or shifts if required.
  • Ability to stand, walk, and perform repetitive tasks.
  • Ability to lift up to 25 lbs.
 
Why Should You Apply? 
ICONMA is an Equal Opportunity Employer. All qualified applicants will receive considerationfor employment without regard to any status protected by applicable law.

About the Company

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ICONMA, LLC