Description
Summary:
This position is for a Senior BSA to help plan, document, and execute the implementation of Lab IT systems across a number of different manufacturing sites. These sites are global and some travel may be involved.
SKILLS:
Skills/Qualifications:
- 7+ years Business Systems Analyst Experience.
- Quality Lab Systems Knowledge. Qualified candidates will have experience with Thermo LIMS Sample Manager 11, Thermo LIMS 2004 and Chromatography Data Software Empower 3, SDMS NuGenesis and/or similar systems.
- Experience writing user and functional system requirements for Laboratory Information Management Systems (LIMS) and integrations between LIMS and ERP (SAP), and LIMS and CDS (Empower)
- Experience writing use cases
- Excellent communication skills: experience presenting to audience of 20+ business users and IT users and leading business workshops
- Excellent analytical skills: analyze business systems data, make recommendations for standardization across different sites, experience with LIMS calculations
- Experience with validated systems is required: supporting formal software validation in pharmaceutical environment. Leading business and technical testing teams during informal testing (in preparation for validation testing). Experience with incident management, and deviation management.
- Global Experience. Candidates must have experience working with global stakeholders and global travel. Working with different cultures in their own environments and communicating effectively
- Full SDLC Experience. Experience with end to end system work is requested.
- Change Management Experience. The client is anticipating some on the ground resistance to the IT changes. Experience with change management communication while working as a BSA is valued.
- Advanced knowledge of electronic records requirements/compliance protocols (cGMP, GMP, FDA regulations, 21 CFR Part 11)
- In-depth, hands-on, laboratory experience helpful (especially pharmaceutical or chemical)
- Strong project management experience
- Desire and ability to work in a dynamic and fast-paced environment
- Excellent oral and written communications skills
- Excellent organizational skills
- Ability to effectively multitask assignments
- Ability to approach problems with a sense of ownership, enthusiasm and innovation
- Ability to interface with people at all levels of the company
- Strong client service attitude and leadership capabilities
- Provide support after normal work hours when necessary
- Good problem solving skills, analytical ability and judgment
Education:
- Bachelor's degree in Business, Computer Science, Math, Engineering, Chemistry, or equivalent discipline required