cGXP Database Admin II
The University of Massachusetts Medical School - School of Medicine was founded in 1962 to provide affordable, quality medical education to state residents and to increase the number of primary care physicians practicing in underserved areas of the state. Our mission is to advance the health and well-being of the people of the commonwealth and the world through pioneering education, research, and health care delivery with our clinical partner, UMASS Memorial Health Care.
The cGxP Database Administrator II maintains and customizes cGxP databases to ensure high levels of availability and security within an FDA regulated manufacturing and research environment. Responsible for providing full spectrum database administration to a secure LAN and WAN environment which includes effective provisioning, installation/configuration, operation, and maintenance of database systems, software and related infrastructure. Identifies and resolves database performance issues, database capacity issues and other distributed data issues. Recommends and performs database repairs and upgrades as necessary. Ensures that MBL's IS solutions are consistent with organizational goals, industry best practices, and regulatory requirements, including but not limited to cGxP and 21 CFR part 11.
MAJOR RESPONSIBILITIES:
Develops, installs, implements, and maintains Oracle and MS SQL Server databases for a cGxP regulated research & manufacturing facility.
Exercises independent judgment within scope of authority. When appropriate, escalates issues to supervisor to determine appropriate authority level to ensure prompt and appropriate resolution within the context of organizational priorities.
Ensures that data and system backup and recovery mechanisms are in place.
Executes database testing, qualifications, and validations, ensuring consistent functionality and compliance.
Proposes IS solutions based on SME documented user needs. Obtains ratification to prioritize and implement IS solutions. Performs database improvements, upgrades and repairs as necessary.
Provides timely and appropriate support and training to helpdesk staff and end users.
Develops and maintains proper technical and user documentation for each database in a consistent and structured manner. Documents all work according to MBL-IS standards and cGxP. Makes recommendations for SOP revisions and writes change controls.
Ensures that all aspects of all MBL databases adhere to MBL-IS standards, cGxP, and other applicable regulations including but not limited to 21 CFR part 11.
Maintains up to date knowledge of industry trends and best practices.
Maintains effective communication and relationships internally and externally to MBL.
Performs additional job related duties as required.
REQUIRED QUALIFICATIONS;
Requires a bachelor’s degree in Computer Science with a minimum 2 years of relevant experience or equivalent combination of education and experience. Oracle certification required.
Requires solid experience of Data guard implementation.
Demonstrated proficiency in Oracle 9i, Oracle 10g databases is must. A strong working knowledge of MS SQL server 2000, MS SQL server 2005 and MS SQL Server 2008 is desirable.
Ability to follow instructions precisely , recognize deviations, and recommend corrective action
Prior-experience in a cGxP regulated environment preferred. Working knowledge of cGxP, 21CFR part 11, and MA data security regulations preferred.
Demonstrated ability to train others
Ability to conduct complex troubleshooting
Demonstrated proficiency in current and MBL owned versions of MS Operating systems, Oracle and MS SQL Server databases. Experience in the design of database management systems and application development is required
Strong critical thinking, time management and organizational skills. Demonstrated ability to multitask and consistently meet deadlines
Possesses well developed attention to detail, ability to maintain accurate records and excellent proofreading skills.
Excellent written and verbal communication skills. Ability to communicate effectively (up, down, and laterally) with others
Ability to work effectively both independently and as a member of a team
Occasional travel may be required
Ability to work flexible hours and, at times extended hours to meet business needs of a 24 / 7 / 365 manufacturing operation
Ability to routinely lift up to 50 lbs using proper lifting technique (monitors, servers, switches)
Must be able to carry out the essential functions of this position, with reasonable accommodation if disabled.
ADDITIONAL DATA
The successful candidate will have a minimum of 2 years of experience as an Oracle Database Administrator with a focus on Oracle Data Stand-by or Data Guard tools. This position may also include opportunities to learn new computerized data systems and participate in the administration and data management of various Bio-Pharmaceutical Manufacturing and Research computerized systems such as Process Control, Building Control, Laboratory Information Management, Computerized Maintenance Management, and Electronic Document Management
