Quality Control Analyst

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