Quality Control Analyst

1 day ago


Woburn, United States Tandym Group Full time

We have a current opportunity for a Quality Control Analyst on a contract basis. The position will be based in Woburn, MA. For further information about this position please apply.

JOB DESCRIPTION/ JOB SUMMARY

The Quality Control Analyst will be responsible for:
  • Performing Routine QC testing including, but not limited to, quantitative PCR and cell-based assays in a GMP environment to support product release and stability
  • Review and approval of cGMP analytical data for release and stability testing from bioassay test methods including, but not limited to, mRNA expression, functional potency and ELISA testing platforms
  • Support and lead QC Bioassay laboratory operations (ex. Instrument qualification and maintenance. Passage cells, qualify critical reagents, etc.)
  • Author and support quality events; Change Controls, Deviation, CAPA, OOS Investigation, as needed
  • Support method transfer and validation activities for development, technical transfer, and validation of late-stage assays for AAV-based gene therapy programs
  • Author analytical method performance trend reports, as needed
  • Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs)
  • Model leadership behaviors and mentor/train junior staff
  • Work with cross functional teams with both internal and external stakeholders

REQUIREMENTS / QUALIFICATIONS

  • BS in Cell Biology, Biochemistry or a related discipline with minimum 5+ years industry experience
  • Experience in a GMP/GLP environment is a must
  • Experience in a routine mammalian cell culture required
  • Experience with quantitative PCR required
  • Experience with cell-based potency assays required
  • Experience performing immunoassays such as ELISAs strongly desired
  • Experience with statistical analysis (SoftMax, JMP) preferred
  • Strong collaboration, team-working skills, and communication skills
  • Independently motivated and detail-oriented with good problem-solving ability
  • Strong communication, interpersonal and organizational skills


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