GxP Application Specialist

San Rafael, CA 94901

Posted: 12/01/2017 Employment Type: Contract Industry: Process Development Job Number: 3626

The GxP Application Specialist will implement Instrument based software (COTS) in the Quality Control labs. The Application Specialist is a hands on, individual contributor that will help ensure that systems are implemented efficiently (following a standard process) so that the lab can maintain a high standard of efficiency and compliance with current data Integrity requirements.

  • Coordinate projects and manage deliverables across multiple departments (QA, QC, IT etc.).
  • Research software functionality for COTS systems to determine suitability and capability of meeting user requirements
  • Configure software using the standard ‘ out of the box’ interface
  • Draft SDLC documents including FRS, UAT and Test Cases
  • Provide content for ' end user' SOPs, work instructions and training materials
  • Document, and communicate project outcomes (Positive/Negative) to management and participate in efforts to improve the process.
  • Assist in ad-hoc projects as needed to address QC Informatics deviation investigations or initiatives.
  • Perform Post-Go live application support



Must Have:

  • Project coordination experience and organization skills.
  • 3 years in a Pharmaceutical/Biotech environment preferably with either lab experience or software implementation experience
  • Positive communication skills (written and verbal), including lateral management, meeting management, and negotiation skills.
  • Microsoft Office (or similar) application skills
  • Minimum 1 year of Systems Analysis experience, including troubleshooting and root cause analysis

Highly Desired Experience:

  • Common software solutions used in the QC lab (SoftMax Pro, Empower, LIMS, ELN,  etc)
  • Standard software development methodologies (Agile, Waterfall, etc.)
  • 21CFR Part 11, GAMP, ALCOA+


Minimum: BA/BS degree OR six years direct experience in a similar role

Additional Desired: PMI and/or ASQ (CSQE) certification

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