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Senior IT Systems Analyst- Manufacturing/Regulatory
From:
Company: Orthovita, Inc (see all of this employer's jobs)
Phone: 6104075233
Fax: 1234567890
 Apply by eMail:do_not_reply@invalidemail.com
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Job Reference ID:
4919614
Category:
Information Systems
Duration:
Fulltime, Permanent
City, ST:
Malvern, Pennsylvania
Country:
United States |
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Description:
SUMMARY OF FUNCTIONS:
The Senior IT Systems Analyst is responsible for delivering and maintaining technology solutions to support manufacturing, quality, clinical, regulatory and R&D. Primary focus of the role will be supporting the MasterControl electronic data management system(EDMS), Additional duties include defining business process needs and requirements, identifying, developing and implementing system solutions.
QUALIFICATION REQUIRMENTS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Manage the maintenance and implementation of system upgrades and enhancements to the MasterControl EDMS system.
Provide end user support for MasterControl EDMS system.
Gather requirements, create design specifications, and develop application enhancements, data interfaces and reports.
Create/Modify SQL objects for scripting, reporting and troubleshooting.
Troubleshoot and assist in resolution of operational issues for software applications
Identify and lead continuous improvement projects partnering with business stakeholders to define project scope, business requirements, project approach, budget, and schedule.
Participate in the design and development of test plans for exeucting unit, integration, system and validation testing ensuring FDA and other regulatory compliance.
Develop and execute software validation protocols for version upgrades
Provide guidance in the areas of industry best practices as well as systems and solutions to improve effectiveness and efficiency.
Ensures all applicable electronic systems, including hardware, software, networks, etc. meet all FDA other regulatory requirements.
Lead vendor and product evaluations of proposed new technology solutions
Manage projects and vendors services for the development and support of custom and package software solutions
SKILLS, EXPERIENCE AND EDUCATIONAL REQUIREMENTS:
· Bachelors Degree (B.A.) from a four-year college or university ; preferably with an area of concentration in Computer Science or Engineering with a minimum of 5 years related experience and/or training
· 5+ years of experience in systems analysis and software development with indepth understanding of the system development life cycle
· Experience with C-based programming languages (particularly JavaScript) and database management SQL Server experience preferred.
· Experience with electronic document management systems in FDA regulated medical device or pharmaceutical company, experience with MasterControl is preferred.
· Knowledge of business processes in one or more areas of manufacturing, quality control, regulatory, clinical, R&D
· Knowledge of and experience with cGXP Software Validation, applicable FDA regulations and ICH guidelines.-
· Strong skills in the areas of team facilitation, process mapping, solutions requirements gathering and problem solving.
Apply by eMail:do_not_reply@invalidemail.com
Job Created:
Sat Sep 26 2009 05:37:35 AM
Last Modified: Sat Nov 21 2009 05:39:18 AM
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