We are in search of a QCAnalyst who is HPLC focused. The candidate will affiliate with Analytical Development and Method Validation ensuring successful method transfer, Quality Assurance, IT, Facilities, and other cross-functional teams as required. Also having a background in cGMP operational and technical background in cell biology, biochemistry, and/or molecular biology will be highly desirable in this role. Extensive HPLC experience is required.
About the Role:
- Performing cGMP analytical testing (pH, osmolality, appearance, bioassay, cell culture, flow cytometry, qPCR, and ELISA)
- Evaluate and review raw data (peer review level)
- Write SOPs/Forms and technical reports with guidance
- Initiate laboratory deviations and support investigations (IA, OOS, AR), performing assessment, authoring protocols/reports and investigation closure with guidance
- Author, review, and execute equipment validations with guidance
- Assist operational systems (equipment/instrument maintenance/calibration, equipment alarm monitoring, sample handling/tracking, data integrity/control, cGMP documentation, LIMS, laboratory audit, and method training)
- Execute phase-appropriate test method validation protocols as needed
- Participate in providing the necessary information for regulatory filings and inspections.
- Assist CAPA/Continuous Improvement Initiatives
- BS with a minimum of 4 years in a biotechnology discipline
- A minimum of 4 years of experience in a cGMP/GxP environment is preferred
- HPLC experience
- Outstanding organizational, analytical, and communications skills and having a "do-what-it-takes" attitude
- A strong passion for addressing the critical unmet medical needs of patients
- Self-directed individual who is able to work with limited direction in a fast-paced, goal-oriented environment
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.