Job Title

• QA Specialist
  

Position Description

• Quality Assurance Specialist with combination of education, experience, and training to effectively review and approve Commissioning, Qualification, and Validation (CQV) lifecycle deliverables associated with facilities, utilities, equipment, instruments, and computerized systems supporting Investigational Medicinal Products and Clinical Supply Operations.
  

Position Requirements

• Solid understanding of the CQV requirements pertaining to GMP regulated operations. Demonstrated knowledge and experience in application of industry accepted CQV standards and guidelines (ICH, ISPE, ISO, ATSM, PDA, GAMP 21 CFR 211, 21 CFR 11 etc.)  
• Strength in the qualification of analytical and microbiological laboratory instrumentation and equipment, computerized and non-computerized.
• Provide support to the Functional Area analytical instrument/ equipment qualification activities
• Review and approve pre-executed and post-executed Installation/Operational/Performance Qualification Protocols
• Review Instrument and equipment related Work Instructions for quality and compliance issues 
• Familiarity with instruments, equipment and utilities supporting analytical labotaory operations (i.e. High Pressure Liquid Chromatograph, Gas Chromatograph, Atomic Absorption Spectroscopy, Ultra Violet Spectroscopy, Karl Fisher, Freezers, Refrigerators, Incubators, Water Systems, HVAC Units)
• Conduct review of documentation for compliance to and FDA regulated policies
• Review change control documentation for applicability to standards
• Communicate any identified or potential problems to supervisor 
  

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance