GxP Application Specialist
770 Lindaro St San Rafael, CA 94901
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
- 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