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Staffing - Technician I
Ref No.: 17-15551
Location: Manassas, Virginia
Job Title: Technician I
Job Location: Manassas, VA
Job Duration: 6 months plus


Note:
  • This is a non-exempt position
  • Second shift position (2pm-11pm/Mon Fri).
 
Experiences/Education:
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
 
Role Purpose:
  • 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.
 
Key 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