Quality Control Analyst

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

• 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