QA Document Control Specialist

StemCells Inc.

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Location: Mountain View, CA Posted Date: 5/2/2013 Position Type: Full time Job Code: QA DOC-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 QA Document Control Specialist.  This position will support the administration and execution of the Company’s document control quality systems in compliance with GxP’s and Company policies.  Responsibilities will include:

• Provide support for processing controlled documents through the change control process
• Edit documents that are being routed for changes and revision ensuring that changes are accurately tracked
• Work with reviewers of documents to ensure that review of documents are performed in a timely manner
• Issue DCRs
• Track in-process DCRs and obtain signatures
• Compilation and filing of documents
• Scanning
• Archiving
• 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-DOC- 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 document control experience in the biotechnology or pharmaceutical industry.  
• Must have experience with MS Word, Adobe Acrobat Professional, MS Excel, PowerPoint, SharePoint
• Must have strong knowledge of cGMPs and cGCPs
• Proven record working in a fast-paced multi-disciplinary project team environment
• Must have excellent oral and written communication skills

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