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Quality Assurance Analyst

StemCells Inc.

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Location: Mountain View, CA Posted Date: 4/23/2013 Position Type: Full time Job Code: QA-BSP Required Education: Bachelors Degree Areas of Expertise Desired: Quality Assurance

Description

StemCells, Inc. is engaged in the research, development, and commercialization of cell-based therapeutics and tools for use in stem cell-based research and drug discovery. The Company’s lead therapeutic product candidate, HuCNS-SC® cells (purified human neural stem cells), is currently in development as a potential treatment for a broad range of central nervous system disorders.  Clinical trials are underway in Spinal Cord Injury and dry Age-related Macular Degeneration.  StemCells also markets a range of stem cell research products under the SC Proven® brand, and offers contract cell process development and production services.

We are currently seeking a Quality Assurance Analyst.  This position will support the implementation and management of the Company’s quality systems in compliance with cGMPs and other Company policies.  Other responsibilities include:

• Perform compliance review of the batch records for both in-house and externally manufactured product including in-process testing, releasing after final QC check, labeling, packaging, and all supporting documentation
• Release raw materials and components
• Conduct investigations relating to manufactured products and raw materials
• Assist in oversight of the CAPA Program
• Release final cell-based therapeutic products for clinical applications
• Assist in the audit internal departments, external suppliers, and service providers and complete report of findings
• Provide QA and validation input for the development, review, and approval of processes, test methods, software applications, equipment, utility systems, and laboratory instruments
• Review and approve validation and qualification packages including installation, operation, and performance qualifications (IQ, OQ, PQ) protocols and reports
• Other duties as assigned

StemCells, Inc. offers a comprehensive and competitive compensation package, as well as generous paid time off in addition to Company observed holidays, and Medical, Dental and Life Insurance. We promote a culture in which employees are respected and rewarded for hard work, innovation, personal initiative, and teamwork.  

For more information about StemCells, Inc., please visit http://www.stemcellsinc.com.

To apply, please send your resume/CV to staffing@stemcellsinc.com, Subject: QA–BSP or FAX your resume/CV to: Staffing at 510-456-4001.  No phone calls please.

Direct applicant only; no agencies, please.  EOE.

Requirements

Candidate must possess:
• BA/BS degree in Science or equivalent with at least four years of direct QA experience related to GMP Manufacturing in the biotechnology or pharmaceutical industry.  
• Experience in cell-based therapeutics or biopharmaceuticals preferred.
• Must have strong knowledge of cGMPs
• Proven record working in a multi-disciplinary project team environment
• Must have excellent oral and written communication skills
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