Quality Control Analyst
Aeras - Rockville, MD

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POSITION SUMMARY:

The incumbent will join the QC team to perform duties as required within the Quality Control testing and support operations.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Performs all routine QC assay analysis not limited to Bioburden, Endotoxin Testing, CFU, Water collection, Growth promotion etc.
  • Performs Environmental Monitoring, Reviews EM test data, EM Trend Report and Remediation.
  • Participate in the validation of HVAC, Methods and Processes.
  • Conduct data entry & trend analysis of data.
  • Participate and perform special studies & projects assigned to the Quality Control Laboratory.
  • Performs autoclaving and maintenance of all QC Equipment and Housekeeping associated with the lab.
  • Order, receive & release QC Media, buffer solutions and supplies.
  • Perform peer review of all QC Laboratory data as applicable.
  • Follow proper safety measures and policies of the lab while working in the

lab.

  • Participate in investigations for OOS test results and initiates investigation using the Trackwise system.
  • Write, Revise and Review QC protocols and reports as needed.
  • Write, review and/or revise QC SOPs as needed.
  • Assists in the performance and qualification of other analysts on QC assays that they are a subject matter expert on.
  • Perform tracking of equipment needing calibration.
  • Perform Microbial isolate qualification, processing and identifications as needed.
  • Initiate QC Specifications, Bill of Test, and Certifications of Testing as needed.
  • Initiate and document stability testing program for products undergoing stability testing.

QUALIFICATIONS AND REQUIREMENTS:

Familiarity with cGMP and computer skills a plus.

Education Requirements: BS in Microbiology, Biology, Cell Biology; or equivalent experience with 5-7 years experience or MS in Microbiology, Biology, Cell Biology; or equivalent experience with over 2 years experience in a pharmaceutical or biotech environment.

Aeras is an Equal Opportunity Employer. M/F/D/V


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About this company
Aeras is constantly producing new constructs that will also be made available following phenotypic, genotypic and stability...