Quality Control Analyst
1 month ago
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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