QC Lab Technician

US-VA-Manassas
2 weeks ago
Job ID
2017-28014
Category
Engineering
Position Type
Contract (Full-Time)
# of Openings
1

Overview

QC Lab Technician

*Second shift position( 2pm-11pm/Mon Fri).

Tests and inspects products at various stages of the production process in order to determine and maintain the quality and reliability of products. Achieve department requirements for safety, quality, product release, equipment uptime, sample throughput, and cost. Ensures goods are tested to meet release commitments.

Responsibilities

  • Perform in process testing including pH, osmolality, rapid endotoxin test, TOC, conductivity, and density 
  • Perform line clearances in support of liquid manufacturing and powder manufacturing 
  • Distribute manufacturing samples to retention/stability storage (as appropriate) and staging locations for post-production testing 
  • Testing responsibilities in one or more of the following areas: 
  • Microbiology: 
  • Perform and review biological/microbiological testing including sterility, bacteriastasis/fungistasis, antibiotic microbial assay, microbial limits, mycoplasma testing, powder bioburden, lymphocyte separation testing, USP/EP growth promotion, organism isolation/identification 
  • Perform and review environmental monitoring of cleanrooms including viable and non-viable air sampling and surface sampling in order to evaluate cleanliness 
  • Chemistry: 
  • Perform and review wet chemistry testing on raw materials and finished products as well as perform USP/EP WFI testing of water products 
  • Perform and review biochemical assays including DNase, RNase, Protease, glucose, protein, chloride, hydrogen peroxide, glutamine, kinetic chromogenic endotoxin testing, and powder particle size/moisture testing 
  • Cell Culture: 
  • Perform and review cell culture testing including plating efficiency, kill curve, two week growth promotion, confirmatory testing, toxicity testing, and trypsin testing 
  • Train QC personnel, ensuring procedures are being followed correctly and in compliance with established safety and training programs 
  • Inspect products at various stages of the production process in order to determine and maintain their quality and reliability and provide backup support to the QC inspector position when necessary 
  • Perform verification of calibration and preventive maintenance of equipment and keep the equipment in general working order within the laboratory

Qualifications

In addition to the job description the right candidate must be experienced with Cell culture and biological assay testing.

Required:
• Minimum of 2 year degree in a science related field, including microbiology, chemistry, biology, biochemistry, with 1 to 2 years of relevant experience.
• Proficiency in Microsoft Word and Excel
• Must be detail-oriented
• Able to work well both independently and in a group setting

Desired:
• Bachelor’s degree desired
• Familiarity with cGxP environments and QC testing methodologies (e.g. pH, osmolality, density, endotoxin, sterility, cell culture, and microbiological methods)
• Prior experience performing testing and track record of delivering results
• Understanding of Manufacturing processes for product formulation, CIP, SIP, and Torque & Fill

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