QA Specialist I
We are seeking a Quality Assurance Associate I for a biotechnology company focused on spearheading breakthroughs in regenerative medicine using adult, autologous Mesenchymal Stem Cells (MSCs). The Cell Manufacturing Associate will be an integral part of the laboratory manufacturing team.
Quality Assurance Associate I
- Assist with document control, records management and review of manufacturing batch records.
- Keep files and documents organized, working with both paper and electronic records.
- Help maintain the Quality Assurance document control system, while making sure documents are stored and labeled appropriate
• Issuance and review of Manufacturing Batch Records
• Issuance of Deviation/Non- Conformance and CAPA numbers
• Receive, track and file-controlled documents, such as monthly LUMAC logs, batch records, Quality Control testing logs, training records etc.
• Be proactive in informing the team members of documents in jeopardy of being late
- Good Manufacturing Practice (GMP), preferred but not required
- Excellent organizational skills and attention to detail
- Demonstrate skills to plan, organize, analyze, and resolve problems with excellent interpersonal, verbal and written communication skills
- Bachelor’s degree in life sciences, pharmaceutical, biotech or related fields and
- 1+ year working knowledge of FDA requirements and cGMP documentation in a regulated biotechnology or pharmaceutical environment. OR
- Associate degree in life sciences, pharmaceutical, biotech or related fields and 2+ years working knowledge of FDA requirements and cGMP documentation in a regulated biotechnology or pharmaceutical environment.
This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!