Quality Control Analyst

1 month ago


Woburn, United States Planet Pharma Full time

1-Year Contract

$50-$59/Hour


Responsibilities:

  • 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.
  • Supports and leads 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

Qualifications:

  • BS in Cell Biology, Molecular Biology, Biochemistry or a related discipline with minimum 5+ years industry experience
  • Experience in a GMP/GLP environment is a must.
  • Experience in routine mammalian cell culture required
  • Experience with quantitative PCR required. Experience with cell-based potency assays is required. Experience performing immunoassays such as ELISAs strongly desired
  • Experience with statistical analysis (SoftMax, JMP) preferred
  • Ability and desire to work in a fast-paced environment
  • 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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