Business System Analyst

This is a Business System Analyst position with a strong and very successful biopharmaceutical / biomedical company focusing with cardiovascular emphasis.

The Business System Analyst will be a vital member of a team responsible for defining, implementing, enhancing, and supporting electronic document management and web portal applications, in support of regulatory compliance, quality assurance and commercialization.

IF INTERESTED PLEASE SEND RESUME TO [Click here for email] AS A MICROSOFT WORD ATTACHMENT.
REQUIREMENTS
Major Responsibilities/Accountabilities:

A. Essential functional duties of the position

Provide operational supports to end-users of document/record management systems, electronic collaboration system, and intranet web portal.

Participate in all phases of project management for software implementation, including requirements gathering, analysis, configuration, testing, training, production support and maintenance.

Create or organize SOPs, guidelines, and work instructions for IT operations.
Provide coordination or leadership for computerized systems validation, such as IQ/OQ/PQ relative to compliance of 21 CRF Part 11.

B. Other responsibilities/accountabilities (marginal functions)

Contribute to improvement of user interface and help promote user adoption of software.
Relevant Quantitative Dimensions (e.g., budget, supervisory responsibilities):

Help develop or update project plans to control scope, cost, and timeline. Help establish and aggregate performance metrics for project team members. Analyze system performance data for decision-support relative to process/technology changes.

Knowledge/Skill Requirements

Must have a Bachelor's in MIS, business, science, or a technology field.

Must have at least 3 years of experience as an IT professional, document management professional or business analyst.
Strong oral and written communication skills. Training skills a plus.
Practical knowledge of computer systems validation.
Proficient with MS Office, Visio, and MS Project.
Hands-on experience with Document Management Systems and web portals.
Knowledge of system development lifecycle (SDLC) methodology.


Other

2-plus years experience in the biotech, pharmaceutical or medical device industry.
Familiarity with GxP and 21 CFR Part 11.