Sr. QC Analyst
Sr. QC Analyst
Join our client's mission in delivering invigorating gene therapies that reconstruct the lives of patients. Every function is directly or indirectly held accountable for the lives of patients. The ideal Sr. QC Analyst will be responsible for routine/non-routine QC sampling and testing according to Standard Operating Procedures (SOPs). Strong background with HPLC, ELISA and PCR.
About the Role:
- Carryout cGMP analytical testing (pH, osmolality, appearance, bioassay, cell culture, flow cytometry, qPCR, and ELISA)
- Review and evaluate raw data (peer review level)
- Create SOPs/Forms and technical reports with guidance
- Begin laboratory deviations and support investigations (IA, OOS, AR), performing assessment, authoring protocols/reports and investigation closure with guidance
- Create, review, and execute equipment validations with guidance
- Help operational systems (equipment/instrument maintenance/calibration, equipment alarm monitoring, sample handling/tracking, data integrity/control, cGMP documentation, LIMS, laboratory audit, and method training)
- Carryout phase-appropriate test method validation protocols as needed
- Take part in providing the necessary information for regulatory filings and inspections.
- Help CAPA/Continuous Improvement Initiatives
- BS with a minimum of 4 years in a biotechnology discipline
- Minimum of 4 years of experience in a cGMP/GxP environment is preferred
- Ideally hands on experience in cell culture, flow cytometry, quantitative PCR, and other bioanalytical methods such as ELISA
- Superb organizational, analytical, and communications skills and "do-what-it-takes" attitude
If you or someone you know in your network is interested in this position, then please send an updated resume to the attention of N.Silvera (AT SIGN) realstaffing.com and her team at Real Staffing Boston.
Sthree US is acting as an Employment Business in relation to this vacancy.