Seraxis is a rapidly growing biotech company, developing therapies in the cutting edge field of stem cells and regenerative medicine. Specifically, Seraxis is on the exciting mission of curing diabetes.
We are seeking an outstanding and motivated QC Scientist to join our dynamic team. The QC Scientist will determine and document the quality of raw materials, in-process and finished cell therapy product (lot release) in a cGMP environment. The QC Scientist will also validate test methods for routine and non-routine QC analysis in compliance with FDA/ cGMP/ GLP regulations and the Company’s internal procedures. The position requires demonstrated technical knowledge and strong commitment to quality, compliance and scientific excellence.
The job responsibilities include:
• Help finalize product specs, acceptance criteria, rationale and justification for identity, Purity, Potency and Sterility
• Assist with the implementation of QC test methods
• Prepare and execute qualification protocols and reports
• Write and execute stability protocols in compliance with internal SOPs and ICH guidelines, and reports on the results
• Support SOPs writing
• Help prepare Raw Material Specification Sheets, Quality Assurance Control Sheets, Batch records sheets and other required documents
• Collaborate with internal teams to resolve quality issued related to facility, products manufactured and released
• Participate in quality audits as needed
Qualifications and Skills
MS degree or PhD in biochemistry, cell or molecular biology with demonstrated working experience in GMP Quality Control and laboratory environment
• Hands-on experience with techniques such as ELISA, flow cytometry, immunohistochemistry staining, qPCR and cell-based assays
• Must master aseptic cell culture technique and be experienced working in clean rooms
• Experience with cGMP and quality system, including deviations reporting, compliance events, change control, failures, corrective and preventive actions
• High attention to details, excellent organization skills
• Excellent oral and written communication skills
• Demonstrated ability to work independently in a cross-functional team environment
Seraxis is an Equal Opportunity Employer. Please email cover letter and resume to Carole Welsch at email@example.com.